Department of Health and Human Services July 2016 – Federal Register Recent Federal Regulation Documents

Pursuant to 29 U.S.C. 671, notice is given that the National Institute for Occupational Safety and Health (NIOSH) is soliciting proposals for entities and organizations to host and maintain the Buy Quiet Web Tool and the Database of Noise Levels for Machinery and Power Tools through a non-exclusive license. This web tool and database are intended to provide guidance regarding the Buy Quiet program and provide information on how to adopt a Buy Quiet program as well as provide information about machinery and equipment noise levels. It is the goal of these online resources to inform at-risk individuals and their organizations about occupational noise exposures and practical ways to reduce noise-induced hearing loss. NIOSH will grant a non- exclusive license for the maintenance and hosting of the web tools. The preferred qualifications of the grantee organization are detailed in the SUPPLEMENTARY INFORMATION section below.

In compliance with the Paperwork Reduction Act of 1995 which requires 30 days for public comment on proposed information collection projects, the Indian Health Service (IHS) is submitting to the Office of Management and Budget (OMB) a request for an extension of a previously approved collection of information titled, ``Indian Health Service Medical Staff Credentials and Privileges Files,'' OMB Control Number 0917-0009, which expires August 31, 2016. This proposed information collection project was previously published in the Federal Register (81 FR 23318) on April 20, 2016, and allowed 60 days for public comment. The IHS received no public comments regarding this collection. The purpose of this notice is to allow 30 days for public comment to be submitted directly to OMB. Proposed Collection: Title: 0917-0009, ``Indian Health Service Medical Staff Credentials and Privileges Files.'' Type of Information Collection Request: Extension, without revision, of currently approved information collection, 0917-0009, ``Indian Health Service Medical Staff Credentials and Privileges Files.'' Form Numbers: 0917-0009. Need and Use of Information Collection: This collection of information is used to evaluate individual health care providers applying for medical staff privileges at IHS health care facilities. The IHS operates health care facilities that provide health care services to American Indians and Alaska Natives. To provide these services, the IHS employs (directly and under contract) several categories of health care providers including: Physicians (M.D. and D.O.), dentists, psychologists, optometrists, podiatrists, audiologists, physician assistants, certified registered nurse anesthetists, nurse practitioners, and certified nurse midwives. IHS policy specifically requires physicians and dentists to be members of the health care facility medical staff where they practice. Health care providers become medical staff members, depending on the local health care facility's capabilities and medical staff bylaws. There are three types of IHS medical staff applicants: (1) Health care providers applying for direct employment with IHS; (2) contractors who will not seek to become IHS employees; and (3) employed IHS health care providers who seek to transfer between IHS health care facilities. National health care standards developed by the Centers for Medicare and Medicaid Services, the Joint Commission, and other accrediting organizations require health care facilities to review, evaluate and verify the credentials, training and experience of medical staff applicants prior to granting medical staff privileges. In order to meet these standards, IHS health care facilities require all medical staff applicants to provide information concerning their education, training, licensure, and work experience and any adverse disciplinary actions taken against them. This information is then verified with references supplied by the applicant and may include: Former employers, educational institutions, licensure and certification boards, the American Medical Association, the Federation of State Medical Boards, the National Practitioner Data Bank, and the applicants themselves. In addition to the initial granting of medical staff membership and clinical privileges, the Joint Commission standards require that a review of the medical staff be conducted not less than every two years. This review evaluates the current competence of the medical staff and verifies whether they are maintaining the licensure or certification requirements of their specialty. The medical staff credentials and privileges records are maintained at the health care facility where the health care provider is a medical staff member. The establishment of these records at IHS health care facilities is a Joint Commission requirement. Prior to the establishment of this Joint Commission requirement, the degree to which medical staff applications were maintained at all health care facilities in the United States that are verified for completeness and accuracy varied greatly across the Nation. The application process has been streamlined and is using information technology to make the application electronically available on the Internet. The application may be found at the IHS.gov Web site address: https://www.ihs.gov/IHM/ index.cfm?module=dsp_ihm_pc_p3c1_ex#ManualExhibit3-1-A. Affected Public: Individuals and households. Type of Respondents: Individuals. The table below provides: Types of data collection instruments, Estimated number of respondents, Number of annual number of responses, Average burden per response, and Total annual burden hours.

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. To Submit Comments and for Further Information: To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Dr. Sophia Jeon, Health Science Policy Analyst, Office of Science Policy and Planning (OSPP), NINDS, NIH, 31 Center Drive, Building 31, Room 8A03, Bethesda, MD 20892, or call non-toll-free number (301) 435-7571, or Email your request, including your address to: sophia.jeon@nih.gov Formal requests for additional plans and instruments must be requested in writing. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. Proposed Collection: National Institute of Neurological Disorders and Stroke Federal Interagency Traumatic Brain Injury Research (FITBIR) Data Access Request, 0925-0677, Expiration Date 08/31/2016 Reinstatement without change, National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH). Need and Use of Information Collection: The FITBIR Informatics System Data Access Request form is necessary for ``Recipient'' Principal Investigators and their organization or corporations with approved assurance from the DHHS Office of Human Research Protections to access data or images from the FITBIR Informatics System for research purposes. The primary use of this information is to document, track, monitor, and evaluate the use of the FITBIR datasets, as well as to notify interested recipients of updates, corrections or other changes to the database. Type of respondents affected by this information collection are researchers, such as Principal Investigators (PI), who are interested in obtaining access to study data and images from the FITBIR Informatics System for research purposes. There are two scenarios for completing the form. The first is where the Principal Investigator (PI) completes the entire FITBIR Informatics System Data Access Request form, and the second where the PI has the Research Assistant begins filling out the form and PI provides the final reviews and signs it. The estimated annual burden hours to complete the data request form are listed below. OMB approval reinstatement is requested for 3 years. The total estimated annualized burden hours are 63.

Under the provisions of section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Division of Loan Repayment (DLR), the National Institutes of Health (NIH), has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on February 19, 2016, and page numbers 8514-8516, and allowed 60 days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The NIH may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRA_submission@omb.eop.gov or by fax to 202-395-6974, Attention: NIH Desk Officer. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30 days of the date of this publication.

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Use of Standards in FDA Regulatory Oversight of Next Generation Sequencing (NGS)-Based In Vitro Diagnostics (IVDs) Used for Diagnosing Germline Diseases.'' As part of the White House's Precision Medicine Initiative (PMI),\1\ FDA is issuing this draft guidance to provide FDA's proposed approach on the content and possible use of standards in providing oversight for targeted and whole exome human DNA sequencing (WES) NGS-based tests intended to aid in the diagnosis of individuals with suspected germline diseases or other conditions. This document provides recommendations for designing, developing, and validating NGS-based tests for germline diseases, and also discusses possible use of FDA-recognized standards for regulatory oversight of these tests. These recommendations are based on FDA's understanding of the tools and processes needed to run an NGS-based test along with the design and analytical validation considerations appropriate for such tests. This draft guidance is not final nor is it in effect at this time.

The Food and Drug Administration (FDA) is announcing the issuance of an Emergency Use Authorization (EUA) (the Authorization) for an in vitro diagnostic device for detection of the Zika virus in response to the Zika virus outbreak in the Americas. FDA issued this Authorization under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as requested by Hologic, Inc. The Authorization contains, among other things, conditions on the emergency use of the authorized in vitro diagnostic device. The Authorization follows the February 26, 2016, determination by the Secretary of Health and Human Services (HHS) that there is a significant potential for a public health emergency that has a significant potential to affect national security or the health and security of U.S. citizens living abroad and that involves Zika virus. On the basis of such determination, the Secretary of HHS declared on February 26, 2016, that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection of Zika virus and/or diagnosis of Zika virus infection, subject to the terms of any authorization issued under the FD&C Act. The Authorization, which includes an explanation of the reasons for issuance, is reprinted in this document.

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 (the 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 associated with medical devices third-party review under the Food and Drug Administration Modernization Act.

This final rule increases access to medication-assisted treatment (MAT) with buprenorphine and the combination buprenorphine/ naloxone (hereinafter referred to as buprenorphine) in the office-based setting as authorized under the United States Code. Section 303(g)(2) of the Controlled Substances Act (CSA) allows individual practitioners to dispense or prescribe Schedule III, IV, or V controlled substances that have been approved by the Food and Drug Administration (FDA). Section 303(g)(2)(B)(iii) of the CSA allows qualified practitioners who file an initial notification of intent (NOI) to treat a maximum of 30 patients at a time. After 1 year, the practitioner may file a second NOI indicating his/her intent to treat up to 100 patients at a time. This final rule will expand access to MAT by allowing eligible practitioners to request approval to treat up to 275 patients under section 303(g)(2) of the CSA. The final rule also includes requirements to ensure that patients receive the full array of services that comprise evidence-based MAT and minimize the risk that the medications provided for treatment are misused or diverted.

Deaths from drug overdose have risen steadily over the past two decades and have become the leading cause of injury death in the United States. Prescription drugs, especially opioid analgesicsa class of prescription drugs such as hydrocodone, oxycodone, morphine, and methadone used to treat both acute and chronic painhave been increasingly implicated in drug overdose deaths over the last decade. Alarmingly, deaths related to opioid analgesic overdose have quadrupled since 1999, and this increase in deaths has been linked to parallel increases in opioid prescribing. As part of its comprehensive response to the opioid epidemic, HHS is actively working to stem overprescribing of opioids in a number of ways, including by providing clinicians with the tools and education they need to make informed prescribing decisions. In particular, HHS has developed a number of activities that support opioid analgesic prescriber education. This Request for Information (RFI) seeks comment on the most promising approaches in prescriber education and training programs and effective ways to leverage HHS programs to implement/expand them.

This final rule implements requirements under Section 105 of the Medicare Access and CHIP Reauthorization Act of 2015 that expand how qualified entities may use and disclose data under the qualified entity program to the extent consistent with applicable program requirements and other applicable laws, including information, privacy, security and disclosure laws. This rule also explains how qualified entities may create non-public analyses and provide or sell such analyses to authorized users, as well as how qualified entities may provide or sell combined data, or provide Medicare claims data alone at no cost, to certain authorized users. In addition, this rule implements certain privacy and security requirements, and imposes assessments on qualified entities if the qualified entity or the authorized user violates the terms of a data use agreement required by the qualified entity program.

The Office for Human Research Protections (OHRP) announces the opportunity for non-federal public and private sector entities to co- sponsor OHRP Educational Workshops. Potential co-sponsors must have an approved Federal-wide Assurance with OHRP, be recipients of HHS grants for human subject research, and have a demonstrated interest and experience in the protection of human subjects in research. Potential co-sponsors must be willing to participate substantively in the co- sponsored activity.

The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces the availability of the following publication: National Institute for Occupational Safety and Health (NIOSH) Quality Assurance Review of B Readers' Classifications Submitted in the Department of Labor (DOL) Black Lung Benefits Program.

The invention listed below is co-owned by an agency of the U.S. Government and is available for licensing and/or co-development 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. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing and/or co-development.

The Administration for Community Living (ACL) is announcing the award of supplemental funding for the National Paralysis Resource Center (PRC) that was included in the 2016 Congressional budget appropriations. The National Paralysis Resource Center is operated by the Christopher and Dana Reeve Foundation, which offers important programmatic opportunities for persons with disabilities and older adults. The PRC provides comprehensive information for people living with spinal cord injury, paralysis, and mobility-related disabilities and their families. Resources include information and referral by phone and email in multiple languages including English and Spanish; a peer and family support mentoring program; a military and veterans program; multicultural outreach services; free lending library; quality of life grants; and a national Web site. Program Name: National Paralysis Resource Center. Award Amount: $976,580. Award Type: Cooperative Agreement.