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

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, we) is announcing the following pubic workshop entitled ``Improving the Implementation of Risk-Based Monitoring Approaches of Clinical Investigations.'' This public workshop is convened by Duke University's Robert J. Margolis, MD, Center for Health Policy and supported by a cooperative agreement with FDA. The purpose of the public workshop is to capture stakeholder experiences with risk-based approaches to monitoring of clinical investigations and gather stakeholder input on opportunities to further the implementation of risk-based approaches to monitoring.

The Office Head Start (OHS), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is proposing to collect data on the condition and ownership of American Indian and Alaska Native (AIAN) facilities to meet congressional reporting requirements under the Head Start Act.

The Food and Drug Administration is correcting a notice entitled ``Maximal Usage Trials for Topically Applied Active Ingredients Being Considered for Inclusion in an Over-the-Counter Monograph: Study Elements and Considerations; Guidance for Industry; Availability'' that appeared in the Federal Register of May 10, 2019. The document announced the availability of a guidance for industry. The document was published with the incorrect docket number. This document corrects that error.

The Agency for Healthcare Research and Quality published a document in the Federal Register of May 20, 2019 concerning the impact and use of Evidence-based Practice Center (ECP) Program evidence reviews. This document contained an incorrect deadline date.

The Food and Drug Administration (FDA or Agency) has determined that LUPRON (leuprolide acetate) injection, 1 milligram (mg)/0.2 milliliter (mL), was not withdrawn from sale for reasons of safety or effectiveness.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 this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.

The Agency for Healthcare Research and Quality (AHRQ) is announcing a Special Emphasis Panel (SEP) meeting on AHRQ-HS-19-003, ``AHRQ Health Services Research Project: Partners Enabling Diagnostic Excellence (R01).''

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 (PRA).

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 National Program of Cancer Registries Cancer Surveillance System (NPCR CSS). The NPCR CSS provides useful data on cancer incidence and trends.

This document corrects technical errors in the proposed rule that appeared in the April 24, 2019 Federal Register entitled, ``Medicare Program; Inpatient Rehabilitation Facility (IRF) Prospective Payment System for Federal Fiscal Year 2020 and Updates to the IRF Quality Reporting Program.''

In compliance with 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 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) is announcing an amendment to the notice of meeting of the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee. This meeting was announced in the Federal Register of April 24, 2019. The amendment is being made to reflect a change in the DATES portion of the document. There are no other changes.

The Administration for Children and Families (ACF), Office of Planning, Research and Evaluation announces the award of a grant in the amount of $150,000 to the Woodson Center of Washington, DC, to support an environmental scan of models of service for privately managed foster care.

Findings of research misconduct have been made against William W. Cruikshank, Ph.D. (Respondent), former Professor of Medicine, Pulmonary Center, Boston University (BU) School of Medicine. Dr. Cruikshank engaged in research misconduct in research supported by National Cancer Institute (NCI), National Institutes of Health (NIH), grant R01 CA122737-01A2. The administrative actions, including debarment for a period of five (5) years, were implemented beginning on May 13, 2019, and are detailed below.

The Centers for Disease Control and Prevention (CDC) is seeking nominations for membership on the WTCHP STAC. The Centers for Disease Control and Prevention (CDC), in accordance with provisions of the James Zadroga 9/11 Health and Compensation Act of 2010, (42 U.S.C. 300mm-1(a)(2)), is seeking nominations for membership on the World Trade Center (WTC) Health Program STAC. The STAC consists of 17 members including experts in fields associated with occupational medicine, pulmonary medicine, environmental medicine or environmental health, industrial hygiene, epidemiology, toxicology, mental health, and representatives of WTC responders, as well as representatives of certified-eligible WTC survivors. The STAC reviews scientific and medical evidence and makes recommendations to the Administrator of the WTC Health Program on additional Program eligibility criteria and additional WTC-related health conditions, reviews and evaluates policies and procedures used to determine whether sufficient evidence exists to support adding a health condition to the list of WTC-Related Health Conditions, makes recommendations regarding individuals to conduct independent peer reviews of the scientific and technical evidence underlying a final rule adding a condition to the List of WTC- Related Health Conditions, and provides consultation on research regarding certain health conditions related to the September 11, 2001 terrorist attacks. Nominations are being sought for individuals who have expertise and qualifications necessary to contribute to accomplishing the committee's objectives. The Administrator of the WTC Health Program is seeking nominations for members fulfilling the following categories: Occupational physician who has experience treating WTC rescue and recovery workers; Mental health professional; Industrial hygienist; Representative of WTC responders; and Representative of certified-eligible WTC survivors; Physician with expertise in pulmonary medicine. Members may be invited to serve for four-year terms. Selection of members is based on candidates' qualifications to contribute to the accomplishment of STAC objectives. More information on the committee is available at https://www.cdc.gov/wtc/stac.html.

The Office of Community Services (OCS), Administration for Children and Families (ACF) is requesting approval of a three-year extension of the Assets for Independence (AFI) Performance Progress Report (PPR) Long Form and AFI PPR Short Form (OMB #0970-0483, expiration 8/31/2019). There are no changes requested to the forms.

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 information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled ``An Evaluation of CDC's STEADI Older Adult Fall Prevention Initiative in a Primary Care Setting.'' This new data collection effort is an essential component to determine the impact of CDC's Stopping Elderly Accidents, Deaths, and Injuries (STEADI) initiative on falls, emergency department visits, and hospitalizations due to falls.

The Agency for Toxic Substances and Disease Registry (ATSDR), 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 ``National Amyotrophic Lateral Sclerosis (ALS) Registry.'' The National ALS Registry collects information from persons with ALS to better describe the prevalence and potential risk factors for ALS.

The Food and Drug Administration (FDA or Agency) is withdrawing approval of 24 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 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 National Cancer 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 (U.S.) Patents and Patent Applications listed in the Supplementary Information section of this notice to GLG Pharma LLC located in Jupiter, Florida, USA.

The Office of Planning, Research, and Evaluation and the Family and Youth Services Bureau (FYSB) in the Administration for Children and Families propose data collection activities as part of the Sexual Risk Avoidance Education (SRAE) Program Performance Analysis Study (PAS). The goal of the study is to collect, analyze, and report on performance measures data for SRAE programs.

The Scholarships for Disadvantaged Students (SDS) program is authorized by the Public Health Service Act (PHS Act) and administered by HRSA. The program promotes diversity among the health professions and nursing workforce by providing awards to eligible health professions and nursing schools for use in awarding scholarships to students from disadvantaged backgrounds. This notice seeks public comment to inform and guide policy and planning associated with the SDS program.

The U.S. Department of Health and Human Services (HHS) published a document in the Federal Register of May 15, 2019, concerning the establishment of the Interdepartmental Substance Use Disorders Coordinating Committee and Solicitation of Nominations for Committee Members. The document contained an inadvertent omission of the following membership category from the list of non-federal members that the Secretary of HHS will appoint to the committee: Public safety officer with extensive experience in interacting with adults with a substance use disorder.

NIOSH gives notice of a decision to evaluate a petition to designate a class of employees from the West Valley Demonstration Project in West Valley, New York, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000.

In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the NIH will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.

As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that a meeting is scheduled to be held of the National Vaccine Advisory Committee (NVAC). The meeting will be open to the public via teleconference; a public comment session will be held during the meeting.

In accordance with requirements of the Privacy Act of 1974, as amended, the Department of Health and Human Services (HHS) is updating an existing system of records maintained by the Health Resources and Services Administration (HRSA), System No. 09-15-0066 ``State-Provided Physician Records for the Application Submission & Processing System.'' The system of records covers service delivery data pertaining to individual health care providers practicing in eligible primary care, mental health, and dental disciplines, which is used by state partners to apply for, and by HRSA to designate, health professional shortage areas and medically underserved areas and populations. The modifications include adding a unique identifier for providers, known as the National Provider Identifier; and changing the system name to ``Health Professional Service Delivery Data Used to Designate Health Professional Shortage Areas (HPSAs) and Medically Underserved Areas and Populations (MUA/Ps).''

The Agency for Healthcare Research and Quality (AHRQ) is announcing a Special Emphasis Panel (SEP) meeting on AHRQ-HS-19-001, ``Patient Safety Learning Laboratories (2019): Pursuing Safety in Diagnosis and Treatment at the Intersection of Design, Systems Engineering, and Health Services Research (R18).''

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 reporting requirements for submission and listing of patent information associated with a new drug application (NDA), an amendment or a supplement to an NDA.

In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment.

The 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 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 Children's Bureau (CB), Administration for Children and Families (ACF), U.S. Department of Health and Human Services, is proposing to collect data for a new prevention services data collection for children receiving prevention and family services and programs.

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 for the regulations restricting the sale and distribution of cigarettes and smokeless tobacco to protect children and adolescents.

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 U.S. and foreign Patents and Patent Applications listed in the Supplementary Information section of this notice to IVERIC bio, Inc. located in New York, NY.

In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Board of Scientific Counselors, National Center for Injury Prevention and Control, (BSC, NCIPC). There will be 15 minutes allotted for public comments at the end of the open session from 3:40 p.m.-3:55 p.m. on July 17, 2019.

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).

As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that a meeting is scheduled to be held for the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria (Advisory Council). The meeting will be open to the public; a public comment session will be held during the meeting. Pre-registration is required 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 CARB@hhs.gov. Registration information is available on the website https://www.hhs.gov/ash/carb/ and must be completed by July 2, 2019; all in-person attendees must pre-register by this date. Additional information about registering for the meeting and providing public comment can be obtained at https://www.hhs.gov/ash/carb/ on the Meetings page.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Considerations in Demonstrating Interchangeability With a Reference Product.'' This guidance is intended to assist sponsors in demonstrating that a proposed therapeutic protein product is interchangeable with a reference product for the purposes of submitting a marketing application or supplement under the Public Health Service Act (PHS Act). This guidance is one in a series of guidances that FDA has developed to implement the Biologics Price Competition and Innovation Act of 2009 (BPCI Act).

In accordance with the requirements of the Privacy Act of 1974, as amended, HHS is revising a department-wide system of records, System No. 09-90-1601 titled Outside Experts Recruited for Non-FACA Activities, to add records about outside consultants used by HHS' Administration for Children and Families, Office of Trafficking in Persons (ACF/OTIP).

The National Clinical Care Commission (the Commission) will conduct its third meeting on June 27, 2019. The Commission will evaluate and make recommendations to the U.S. Department of Health and Human Services (HHS) Secretary and Congress regarding improvements to the coordination and leveraging of federal programs related to awareness and clinical care for complex metabolic or autoimmune diseases that result from issues related to insulin that represent a significant disease burden in the United States, which may include complications due to such diseases.

AHRQ invites public comment on its Request for Information (RFI) to inform potential revisions to the Consumer Assessment of Healthcare Providers and Systems Health Plan Survey 5.0. The Consumer Assessment of Healthcare Providers and Systems (CAHPS[supreg]) Health Plan Survey 5.0 is one of the CAHPS family of surveys that assess patients' experiences with health care providers, in different settings, and with health plans. The CAHPS surveys cover topics that are important to patients and that they are best able to assess, such as the communication with providers and access to health care services. This RFI requests public comment regarding the relevance and validity of the questions on CAHPS Health Plan Survey 5.0 (the Survey), and any user concerns about revisions to the Survey.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for the GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS 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 medical device.

The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public meeting entitled ``Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments.'' The purpose of the public meeting is to meet performance commitments included in the Prescription Drug User Fee Act (PDUFA) VI, Biosimilar User Fee Act (BsUFA) II, and Generic Drug User Fee Amendments (GDUFA) II. The public meeting will include presentations from FDA on the 5- year plans for the PDUFA VI, BsUFA II, and GDUFA II; the Agency's progress in implementing resource capacity planning and modernized time reporting; and the results of the fiscal year (FY) 2018 evaluation of PDUFA, BsUFA, and GDUFA resource management. The Agency will also address the impact of the modernized fee structure changes on the PDUFA and BsUFA programs and report on the contribution of the BsUFA spending trigger to the BsUFA program.

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.