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

This proposed notice acknowledges the receipt of an application from the Accreditation Commission for Health Care for continued recognition as a national accrediting organization for hospices that wish to participate in the Medicare or Medicaid programs. The statute requires that within 60 days of receipt of an organizations complete application, the Centers for Medicare & Medicaid Services publish a notice that identifies the national accrediting body making the request, describes the nature of the request, and provides at least a 30-day public comment period.

This document summarizes actions taken to date, requests public comment on additional subjects, and announces that CMS is releasing additional material, including study data, related to the Risk Adjustment Data Validation (RADV) provisions of the proposed rule titled ``Medicare and Medicaid Programs; Policy and Technical Changes to the Medicare Advantage, Medicare Prescription Drug Benefit, Program of All-inclusive Care for the Elderly (PACE), Medicaid Fee-For-Service, and Medicaid Managed Care Programs for Years 2020 and 2021'' that was published in the November 1, 2018 Federal Register, 83 FR 55037. The comment period for the RADV provisions of this proposed rule ends on August 28, 2019.

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, the Agency, or we) is announcing a public workshop entitled ``Endpoints for Drug Development in Heart Failure.'' The purpose of this public meeting is to bring the stakeholder community together to discuss clinical endpoints for trials in heart failure that could be used to support FDA approval of drugs. The workshop will focus on endpoints related to symptoms and physical function. In addition, there will be discussion of the need to assess mortality effects of drugs under development for heart failure.

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 Food and Drug Administration (FDA or Agency) is seeking public comment on the Clinical Data Summary Report Pilot program as part of the Agency's continuous assessment of the efficiency and transparency of the clinical data used in the regulatory decision- making process. The Agency is also seeking public feedback on a new integrated review template for the documentation of new drug marketing applications developed as part of the New Drugs Regulatory Program Modernization. The Agency hopes to receive public feedback on both of these efforts and on how FDA might continue supporting our stakeholders' needs related to the clarity and transparency of drug approval decisions.

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 (PRA).

This is to notify the public that the August 8, 2019, meeting of the Advisory Committee on Training in Primary Care Medicine and Dentistry (ACTPCMD) is cancelled. This meeting was announced in the Federal Register, Vol. 84, No. 31 on Thursday, February 14, 2019 (FR Doc. 2019-02318 Filed 2-13-19). Future meetings will occur in calendar year 2020 and be announced at a later date.

The Office of Planning, Research, and Evaluation (OPRE) in the Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS) requests Office of Management and Budget (OMB) approval to modify the previously approved pilot generic clearance (0970-0502) to collect data as part of rapid cycle testing and evaluation, in order to inform the design of interventions informed by behavioral science and to better understand the mechanisms and effects of such interventions. Interventions have been and will continue to be developed in the program area domains of Temporary Assistance for Needy Families (TANF) and child welfare, and this revision would also allow for collection of data in the Early Head Start/Head Start program area. These interventions are intended to improve outcomes for participants in these programs.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Marketing Clearance of Diagnostic Ultrasound Systems and Transducers.'' This final guidance provides detailed recommendations for manufacturers seeking marketing clearance of diagnostic ultrasound systems and transducers, and includes guidance describing the types of modifications to a diagnostic ultrasound device for which FDA does not intend to enforce the requirement for a new premarket notification (510(k)).

As authorized by the Secretary of HHS, AHRQ coordinates the development of common definitions and reporting formats (Common Formats or formats) for reporting on health care quality and patient safety. The purpose of this notice is to announce the availability of Common Formats for SurveillanceHospital Version 0.3 Beta for public review and comment.

This notice acknowledges the Secretary of the Department of Health and Human Services' (the Secretary) receipt and review of the National Quality Forum 2018 Annual Activities Report to Congress and the Secretary submitted by the consensus-based entity under contract with the Secretary in accordance with the Social Security Act. The Secretary has reviewed and is publishing the report in the Federal Register together with the Secretary's comments on the report not later than 6 months after receiving the report in accordance with section 1890(b)(5)(B) of the Social Security Act.

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.

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Clinical Investigations for Prostate Tissue Ablation Devices.'' This draft guidance provides recommendations for clinical investigations for high intensity ultrasound systems for prostate tissue ablation and new types of prostatic tissue ablation devices. This draft guidance is not final nor is it in effect at this time.

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 our guidance document entitled ``Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to the Center for Food Safety and Applied Nutrition.''

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 Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) is updating its Strategic Plan for Fiscal Years (FY) 2020-2024 to help guide the research it supports over the next five years. The Institute issued a previous Request for Information (RFI) (NOT-AR-19-009) to solicit initial comments on how the previous plan for Fiscal Years 2015-2019 should be modified to reflect progress over the past five years. The Institute also gathered additional input through listening sessions with the community. Based on this feedback, along with input from the NIAMS Advisory Council and its Working Group for the Strategic Plan, the Institute has drafted the NIAMS Strategic Plan for FY 2020-2024. We are now seeking input on this draft. Through this RFI, NIAMS invites feedback from researchers in academia and industry, health care professionals, patient advocates and health advocacy organizations, scientific or professional organizations, Federal agencies, and other interested members of the public on the draft NIAMS Strategic Plan for FY 2020-2024. Organizations are strongly encouraged to submit a single response that reflects the views of their organization and membership as a whole. The final draft of the Strategic Plan will be presented at the September 2019 meeting of the NIAMS Advisory Council and the final plan will be posted on the NIAMS website once it is approved.

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 ZOLGENSMA (onasemnogene abeparvovec-xioi), manufactured by AveXis, Inc., meets the criteria for a priority review voucher.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Allergenic Products Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Providing Regulatory Submissions in Electronic and Non-Electronic Format Promotional Labeling and Advertising Materials for Human Prescription Drugs.'' This guidance outlines the requirements and recommendations for various types of submissions of promotional materials for prescription drugs and biological products, including the specific formats needed for use in the electronic common technical document (eCTD) as well as non-eCTD and non-electronic formats. This guidance finalizes the draft guidance issued in April 2015.

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.

In accordance with the Privacy Act of 1974, as amended, the Department of Health and Human Services (HHS), Administration for Children and Families (ACF), Office of Child Support Enforcement (OCSE), is providing notice of a re-established matching program between HHS/ACF/OCSE and state agencies administering the Supplemental Nutrition Assistance Program (SNAP). The matching program compares state SNAP agency records with new hire, quarterly wage, and unemployment insurance information maintained in the National Directory of New Hires (NDNH). The outcomes of the comparisons help state agencies with establishing or verifying eligibility for applicants and recipients of SNAP benefits; reducing SNAP benefit errors; and, maintaining program integrity.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Opioid Analgesic Drugs: Considerations for Benefit-Risk Assessment Framework.'' The purpose of this guidance is to describe the benefit- risk framework the Agency uses in evaluating applications for opioid analgesic drugs. This guidance summarizes the information that should be included in a new drug application (NDA) for an opioid analgesic drug to facilitate the Agency's benefit-risk assessment.

The Food and Drug Administration (FDA, Agency, we) is holding a public hearing on September 17, 2019, entitled ``Standards for Future Opioid Analgesic Approvals and Incentives for New Therapeutics to Treat Pain and Addiction.'' The Agency today is issuing a draft guidance on the application of FDA's existing benefit-risk assessment framework to applications for approval of opioid analgesic drugs. This public hearing is intended to receive stakeholder input on the approval process for new opioids and how FDA might best consider the existing armamentarium of therapies, among other factors, in reviewing applications for new opioids to treat pain. FDA also seeks input on potential new preapproval incentives aimed at fostering the development of new therapeutics to treat pain, as well as new treatments for addiction.

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) 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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on research entitled ``Study of Oncology Indications in Direct-to-Consumer Television Advertising.'' This research consists of two studies examining the presentation of oncology indications in direct-to-consumer (DTC) television ads.

The Food and Drug Administration (FDA or we) is extending the comment period for the notice that appeared in the Federal Register of April 3, 2019. The notice announced a public hearing to obtain scientific data and information about the safety, manufacturing, product quality, marketing, labeling, and sale of products containing cannabis or cannabis-derived compounds. In addition, it notified the public that FDA was establishing a docket for public comment on this hearing and that the docket would close on July 2, 2019. We are extending the comment period to give interested parties more time to comment.

In accordance with the requirements of the Privacy Act of 1974, as amended, the HHS is modifying a system of records maintained by HRSA, Healthcare Systems Bureau (HRSA/HSB), System No. 09-15-0056, ``National Vaccine Injury Compensation Program'' (VICP), and renaming it ``Injury Compensation Programs, HHS/HRSA/HSB.'' The primary purpose of the modification is to include records covered by a related system of records also maintained by HRSA/HSB, System No. 09-15-0071, ``Countermeasures Injury Compensation Program, HHS/HRSA/HSB'' (CICP), in order to consolidate the two systems of records and rescind System No. 09-15-0071.

The Food and Drug Administration (FDA or we) is announcing the availability of a final guidance for industry entitled ``The Declaration of Added Sugars on Honey, Maple Syrup, Other Single- Ingredient Sugars and Syrups, and Certain Cranberry Products.'' This guidance provides clarification on the labeling requirements for single-ingredient packages and/or containers of pure honey, pure maple syrup, and other pure sugars and syrups, which are not required to bear the words ``Includes Xg Added Sugars,'' but must still include the percent Daily Value for added sugars on their labels. This guidance is also intended to advise food manufacturers of our intent to exercise enforcement discretion related to the use of a ``[dagger]'' symbol immediately following the percent Daily Value for added sugars on single-ingredient packages and/or containers of pure honey, pure maple syrup, and other pure sugars and syrups; the ``[dagger]'' symbol would lead the consumer to a statement that is truthful and not misleading in a footnote at the bottom of the Nutrition Facts label. The guidance also advises food manufacturers of our intent to exercise enforcement discretion with respect to the use of a ``[dagger]'' symbol immediately after the added sugars percent Daily Value information that leads the consumer to a statement that is truthful and not misleading outside of the Nutrition Facts label on certain dried cranberry and cranberry beverage products that are made up of cranberry juice sweetened with added sugars and that contain total sugars at levels no greater than comparable products with endogenous (inherent) sugars, but no added sugars. Further, this guidance advises of our intent to exercise enforcement discretion regarding compliance with Nutrition Facts label final rule and Serving Size final rule requirements until July 1, 2021, for the single-ingredient sugars and syrups as well as the cranberry products discussed in the guidance document.

This document sets forth final rules to expand opportunities for working men and women and their families to access affordable, quality healthcare through changes to rules under various provisions of the Public Health Service Act (PHS Act), the Employee Retirement Income Security Act (ERISA), and the Internal Revenue Code (Code) regarding health reimbursement arrangements (HRAs) and other account-based group health plans. Specifically, the final rules allow integrating HRAs and other account-based group health plans with individual health insurance coverage or Medicare, if certain conditions are satisfied (an individual coverage HRA). The final rules also set forth conditions under which certain HRAs and other account-based group health plans will be recognized as limited excepted benefits. Also, the Department of the Treasury (Treasury Department) and the Internal Revenue Service (IRS) are finalizing rules regarding premium tax credit (PTC) eligibility for individuals offered an individual coverage HRA. In addition, the Department of Labor (DOL) is finalizing a clarification to provide assurance that the individual health insurance coverage for which premiums are reimbursed by an individual coverage HRA or a qualified small employer health reimbursement arrangement (QSEHRA) does not become part of an ERISA plan, provided certain safe harbor conditions are satisfied. Finally, the Department of Health and Human Services (HHS) is finalizing provisions to provide a special enrollment period (SEP) in the individual market for individuals who newly gain access to an individual coverage HRA or who are newly provided a QSEHRA. The goal of the final rules is to expand the flexibility and use of HRAs and other account-based group health plans to provide more Americans with additional options to obtain quality, affordable healthcare. The final rules affect employees and their family members; employers, employee organizations, and other plan sponsors; group health plans; health insurance issuers; and purchasers of individual health insurance coverage.

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 a generic clearance to collect information to support social and behavioral research used by FDA about drug products.

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 64th full Council meeting in Jackson, Mississippi. Members will hear a panel presentation regarding Ending the HIV Epidemic: A Plan for America and will discuss possible recommendations regarding programs, policies, and research to promote effective, prevention, treatment and cure of HIV disease and AIDS. 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 Monday, July 1, 2019.

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.

This document corrects technical errors in the proposed rule that appeared in the May 3, 2019, issue of the Federal Register entitled ``Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Proposed Policy Changes and Fiscal Year 2020 Rates; Proposed Quality Reporting Requirements for Specific Providers; Medicare and Medicaid Promoting Interoperability Programs Proposed Requirements for Eligible Hospitals and Critical Access Hospitals.''

HRSA, an Operating Division of HHS, is publishing a list of persons appointed to serve on the Performance Review Board that oversees the evaluation of performance appraisals for Senior Executive Service members within HRSA for the Fiscal Year 2019 and 2020 review period.

Notice is hereby given of the meeting on July 1, 2019, of the Substance Abuse and Mental Health Services Administration's (SAMHSA) National Advisory Council (SAMHSA NAC). This notice may publish with less than 15 days prior to the meeting due to a change in schedule for the committee chair and unexpected calendar changes. The meeting is open to the public and can be accessed via telephone only. Agenda with call-in information will be posted on the SAMHSA website prior to the meeting at: https://www.samhsa.gov/about-us/advisory-councils/meetings. The meeting will include remarks and dialogue from the Assistant Secretary for Mental Health and Substance Use; updates from the SAMHSA Centers Directors, and a council discussion with SAMHSA NAC members.

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 Administration for Children and Families (ACF) at the U.S. Department of Health and Human Services (HHS) seeks approval to conduct a statistically representative survey of directors and managers/ coordinators from Head Start grantee organizations regarding their access to and use of training and technical assistance (T/TA) from multiple sources, including ACF's Early Childhood Training and Technical Assistance system. The purpose of the data collection is to inform ACF on three aspects of grantee directors and managers/ coordinators T/TA experience: (1) Search and selection of T/TA; (2) receipt of T/TA; (3) and potential relationships between T/TA received and perceived change in practice.

In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of Laboratory Animal Welfare (OLAW) in the Office of Extramural Research has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. The purpose of this notice is to allow 60 days for public comment.

The National Heart, Lung and Blood Institute (NHLBI), National Institutes of Health, Department of Health and Human Services, is contemplating amending an existing license to include a exclusive patent license to Molecular Targeting Technologies, Inc. (MTTI); a Delaware corporation, with its principle place of business in West Chester, Pennsylvania, to practice the inventions embodied in the patent application listed in the SUPPLEMENTARY INFORMATION section of this notice.

The Food and Drug Administration (FDA or Agency) 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 information collection aspects of the Guidance for Tobacco Retailers on Tobacco Retailer Training Programs.

This action removes the outmoded HHS regulations for the National Hansen's Disease Program (NHDP). Due to superseding events and statutory changes, NHDP's regulations are obsolete.

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 ``Systematic Review Data Repository.'' In accordance with the Paperwork Reduction Act, AHRQ invites the public to comment on this proposed information collection.

The Food and Drug Administration (FDA) is requesting that any consumer organizations interested in participating in the selection of voting and/or nonvoting consumer representatives to serve on its advisory committees or panels notify FDA in writing. FDA is also requesting nominations for voting and/or nonvoting consumer representatives to serve on advisory committees and/or panels for which vacancies currently exist or are expected to occur in the near future. Nominees recommended to serve as a voting or nonvoting consumer representative may be self-nominated or may be nominated by a consumer organization. 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.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document entitled ``Testing for Biotin Interference in In Vitro Diagnostic Devices; Draft Guidance for Industry.'' The draft guidance document provides FDA's recommendations on the testing for interference by biotin on the performance of in vitro diagnostic devices (IVDs). The draft guidance is intended to help device developers and clinicians understand how FDA recommends biotin interference testing should be performed and how the results of the testing should be communicated to end users, including clinical laboratories and clinicians. FDA also recommends that manufacturers of currently marketed devices consider these draft recommendations.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Arthritis 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 Department of Health and Human Services (``the Department'') is committed to ensuring the civil rights of all individuals who access or seek to access health programs or activities of covered entities under Section 1557 of the Patient Protection and Affordable Care Act. The Department proposes to revise its Section 1557 regulation in order to better comply with the mandates of Congress, address legal concerns, relieve billions of dollars in undue regulatory burdens, further substantive compliance, reduce confusion, and clarify the scope of Section 1557 in keeping with pre-existing civil rights statutes and regulations prohibiting discrimination on the basis of race, color, national origin, sex, age, and disability.

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 extending the comment period for the proposed rule that appeared in the Federal Register of April 2, 2019. The Agency is taking this action in response to requests for an extension to allow interested parties additional time to submit comments.

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 ``Requirements Under the Comprehensive Smokeless Tobacco Health Education Act of 1986, as Amended by the Family Smoking Prevention and Tobacco Control Act.''

The Food and Drug Administration (FDA) is announcing the availability of a final guidance for industry entitled ``Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems, Guidance for Industry.'' Given the relatively new presence of electronic nicotine delivery systems (ENDS) on the U.S. market and FDA's final rule deeming these products to be subject to the tobacco product authorities in the Federal Food, Drug, and Cosmetic Act (FD&C Act), FDA expects to receive premarket tobacco product application (PMTA) submissions from manufacturers of ENDS. This guidance is intended to assist applicants to prepare PMTAs for ENDS products.

The National Advisory Council for Healthcare Research and Quality (the Council) is to advise the Secretary of HHS (Secretary) and the Director of the Agency for Healthcare Research and Quality (AHRQ) with respect to activities proposed or undertaken to carry out AHRQ's statutory mission. AHRQ produces evidence to make health care safer, higher quality, more accessible, equitable, and affordable, and to work within the U.S. Department of Health and Human Services and with other partners to make sure that the evidence is understood and used. Seven current members' terms will expire in November 2019.

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 reporting associated with designation under the Minor Use and Minor Species Animal Health Act of 2004 (MUMS Act).

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: ``Hospital Survey on Patient Safety Culture Comparative Database.'' In accordance with the Paperwork Reduction Act, AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on March 19, 2019, and allowed 60 days for public comment. AHRQ did not receive substantive comments. The purpose of this notice is to allow an additional 30 days for public comment.

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: ``The AHRQ Safety Program for Improving Antibiotic Use.'' In accordance with the Paperwork Reduction Act, AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on April 1, 2019 and allowed 60 days for public comment. AHRQ did not receive substantive comments. The purpose of this notice is to allow an additional 30 days for public comment.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for BAXDELA TABLETS under NDA 208610 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 a patent which claims that human drug product.

The Food and Drug Administration (FDA or Agency) is withdrawing approval of six abbreviated new drug applications (ANDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.

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 investigational device exemptions reports and records.

The Department of Health and Human Services published a document in the Federal Register of June 3, 2019, concerning the opportunity to collaborate on National Youth Sports Initiative to increase youth sports participation with the President's Council on Sports, Fitness & Nutrition (PCSFN). The document contained an incorrect date.

CMS is committed to transforming the health care delivery systemand the Medicare and Medicaid programsby putting additional focus on patient-centered care, innovation, and outcomes. As part of our continuing Patients over Paperwork initiative, we have actively solicited feedback from the medical community through Requests for Information (RFIs), listening sessions, and clinical onsite engagements with front-line clinicians and staff to learn how our administrative requirements and processes affect their daily work and ability to innovate in care delivery. This RFI solicits additional public comment on ideas for regulatory, subregulatory, policy, practice, and procedural changes that reduce unnecessary administrative burdens for clinicians, providers, patients and their families. Through these efforts, we aim to increase quality of care, lower costs, improve program integrity, and make the health care system more effective, simple, and accessible.

The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public workshop entitled ``Leveraging Randomized Clinical Trials to Generate Real-World Evidence for Regulatory Purposes.'' Convened by Duke University's Robert J. Margolis, MD, Center for Health Policy (Duke Margolis) and supported by a cooperative agreement with FDA, the purpose of the public workshop is to bring the stakeholder community together to explore key considerations for using randomized designs, such as large simple trials or those that incorporate pragmatic elements to generate real- world evidence (RWE).

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.