Department of Health and Human Services July 8, 2016 – Federal Register Recent Federal Regulation Documents

Proposed Collection; 60-Day Comment Request: National Institute of Neurological Disorders and Stroke Federal Interagency Traumatic Brain Injury Research (FITBIR) Data Access Request
Document Number: 2016-16256
Type: Notice
Date: 2016-07-08
Agency: Department of Health and Human Services, National Institutes of Health
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.
Public Workshop-Iron Screening and Supplementation of Iron‐Replete Pregnant Women and Young Children
Document Number: 2016-16254
Type: Notice
Date: 2016-07-08
Agency: Department of Health and Human Services, National Institutes of Health
The Office of Dietary Supplements at the National Institutes of Health (NIH) is sponsoring an open public workshop titled, ``Iron Screening and Supplementation of Iron-replete Pregnant Women and Young Children,'' September 28-29, 2016, on the NIH main campus in Bethesda, Maryland. It will also be available to be viewed live or later on- demand as a videocast. The workshop discussions will focus on the U.S. and developed countries and will serve to specify data gaps and research needs by (1) exploring current understanding of iron homeostasis in pregnant women and in young children (6[hyphen]24 months); (2) identifying the challenges associated with measuring iron status and with screening practices; and (3) considering emerging issues associated with routine supplementation of iron[hyphen]replete individuals. All persons are invited to attend, especially clinical educators, those who develop clinical recommendations, health care providers and researchers. Persons wishing to attend are required to register in advance of the conference.
Submission for OMB Review; 30-Day Comment Request National Institutes of Health (NIH) Loan Repayment Programs; Office of the Director (OD)
Document Number: 2016-16227
Type: Notice
Date: 2016-07-08
Agency: Department of Health and Human Services, National Institutes of Health
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.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2016-16220
Type: Notice
Date: 2016-07-08
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
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 any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Use of Standards in the Food and Drug Administration's Regulatory Oversight of Next Generation Sequencing-Based In Vitro Diagnostics Used for Diagnosing Germline Diseases; Draft Guidance for Stakeholders and Food and Drug Administration Staff; Availability
Document Number: 2016-16201
Type: Notice
Date: 2016-07-08
Agency: Food and Drug Administration, Department of Health and Human Services
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.
Use of Public Human Genetic Variant Databases To Support Clinical Validity for Next Generation Sequencing-Based In Vitro Diagnostics; Draft Guidance for Stakeholders and Food and Drug Administration Staff; Availability
Document Number: 2016-16200
Type: Notice
Date: 2016-07-08
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Use of Public Human Genetic Variant Databases to Support Clinical Validity for Next Generation Sequencing (NGS)-Based In Vitro Diagnostics.'' This draft guidance document describes how publicly accessible databases of human genetic variants can serve as sources of valid scientific evidence to support the clinical validity of genotype-phenotype relationships in FDA's regulatory review of next generation sequencing (NGS)-based tests. This draft guidance further outlines the process by which administrators of genetic variant databases could voluntarily apply to FDA for recognition, and how FDA would review such applications and periodically reevaluate recognized databases. This draft guidance is not final nor is it in effect at this time.
Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection of Zika Virus; Availability
Document Number: 2016-16177
Type: Notice
Date: 2016-07-08
Agency: Food and Drug Administration, Department of Health and Human Services
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.
Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection of Ebola Zaire Virus; Availability
Document Number: 2016-16176
Type: Notice
Date: 2016-07-08
Agency: Food and Drug Administration, Department of Health and Human Services
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 Ebola Zaire virus in response to the Ebola virus outbreak in West Africa. FDA issued this Authorization under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as requested by Biocartis NV. The Authorization contains, among other things, conditions on the emergency use of the authorized in vitro diagnostic device. The Authorization follows the September 22, 2006, determination by then-Secretary of the Department of Homeland Security (DHS), Michael Chertoff, that the Ebola virus presents a material threat against the U.S. population sufficient to affect national security. On the basis of such determination, the Secretary of Health and Human Services (HHS) declared on August 5, 2014, that circumstances exist justifying the authorization of emergency use of in vitro diagnostic devices for detection of Ebola virus, 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.
Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Third-Party Review Under the Food and Drug Administration Modernization Act
Document Number: 2016-16158
Type: Notice
Date: 2016-07-08
Agency: Food and Drug Administration, Department of Health and Human Services
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.
Regional Public Workshop on the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use Q3D Implementation of Guideline for Elemental Impurities; Public Workshop
Document Number: 2016-16152
Type: Notice
Date: 2016-07-08
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing a public workshop entitled: Regional Public Workshop on ICH Q3D Implementation of Guideline for Elemental Impurities. The purpose of the public workshop is to elaborate key aspects of the ICH Guideline Q3D: Guideline on Elemental Impurities in order facilitate a harmonized interpretation and implementation by industry and regulators. It is not intended to provide additional guidance beyond the scope of Q3D. The meeting will take place on the FDA campus and also be broadcast on the Web allowing participants to join in person or via the Web.
National Institute of Diabetes and Digestive and Kidney Diseases: Notice of Closed Meetings
Document Number: 2016-16142
Type: Notice
Date: 2016-07-08
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2016-16141
Type: Notice
Date: 2016-07-08
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2016-16140
Type: Notice
Date: 2016-07-08
Agency: Department of Health and Human Services, National Institutes of Health
Office of the National Coordinator for Health Information Technology; Announcement of Requirements and Registration for “Blockchain and Its Emerging Role in Healthcare and Health-related Research”
Document Number: 2016-16133
Type: Notice
Date: 2016-07-08
Agency: Department of Health and Human Services
The ``Blockchain and Its Emerging Role in Healthcare and Health-related Research.'' Ideation Challenge solicits white papers on the topic of Blockchain Technology and the potential use for Healthcare. Winners will be invited to present their submission at an upcoming industry-wide workshop co-hosted with the National Institute of Standards and Technology (NIST). The statutory authority for this Challenge is Section 105 of the America COMPETES Reauthorization Act of 2010 (Pub. L. 111-358).
Medication Assisted Treatment for Opioid Use Disorders
Document Number: 2016-16120
Type: Rule
Date: 2016-07-08
Agency: Department of Health and Human Services
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.
Medication Assisted Treatment for Opioid Use Disorders Reporting Requirements
Document Number: 2016-16069
Type: Proposed Rule
Date: 2016-07-08
Agency: Department of Health and Human Services
On March 30, 2016, the U.S. Department of Health and Human Services (HHS) published a Notice of Proposed Rulemaking (NPRM) to increase the highest patient limit for qualified physicians to treat opioid use disorder under section 303(g)(2) of the Controlled Substances Act (CSA). On July 6, 2016, HHS published a final rule based on the NPRM but delayed finalizing the reporting requirements outlined in the NPRM. In this Supplemental Notice of Proposed Rulemaking (SNPRM), HHS seeks further comment on the same reporting requirements outlined in the NPRM. These reporting requirements would require annual reporting by practitioners who are approved to treat up to 275 patients under subpart F to help HHS ensure compliance with the requirements of the ``Medication Assisted Treatment for Opioid Use Disorders'' final rule published elsewhere in this issue of the Federal Register. HHS will consider the public comments on this SNPRM as well as any comments already received on the March 30, 2016 NPRM before issuing a final rule pertaining to the reporting requirements.
Request for Information: Opioid Analgesic Prescriber Education and Training Opportunities To Prevent Opioid Overdose and Opioid Use Disorder
Document Number: 2016-16067
Type: Notice
Date: 2016-07-08
Agency: Department of Health and Human Services, Office of the Secretary
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.