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

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.

The Food and Drug Administration (FDA or Agency) is extending the comment period for the draft guidance for Industry and Food and Drug Administration Staff entitled ``Public Notification of Emerging Postmarket Medical Device Signals ('Emerging Signals').'' A notice of the availability of the draft guidance and our request for comments appeared in the Federal Register of December 31, 2015. We initially established February 29, 2016, as the deadline for the submission of requested comments that can help improve the Agency's policy for notifying the public about medical device ``emerging signals.'' The Agency is taking this action due to the unanticipated high-level of interest from external stakeholders and the medical device community and will allow interested persons additional time to submit comments.

This notice announces the rescheduling of the March 25, 2016 meeting on the HHS-operated risk adjustment program, which is open to the public. The purpose of this stakeholder meeting is to solicit feedback on the HHS-operated risk adjustment methodology and to discuss potential improvements to the HHS risk adjustment methodology for the 2018 benefit year and beyond. This meeting, the ``HHS-operated Risk Adjustment Methodology Conference,'' will allow issuers, States, and other interested parties to discuss the contents of a White Paper to be published in advance of this meeting. This meeting will also provide an opportunity for participants to ask clarifying questions. The comments and information HHS obtains through this meeting may be used in future policy making for the HHS risk adjustment program.

The Food and Drug Administration (FDA) is requesting that any industry organizations interested in participating in the selection of nonvoting industry representatives to serve on the National Mammography Quality Assurance Advisory Committee (NMQAAC) for the Center for Devices and Radiological Health (CDRH) notify FDA in writing. FDA is also requesting nominations for nonvoting industry representatives to serve on the NMQAAC. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. Nominations will be accepted for current and upcoming vacancies effective with this notice.

The Food and Drug Administration (FDA) is providing interested persons with the opportunity to submit written comments, and to request an informal public meeting concerning recommendations by the World Health Organization (WHO) to impose international manufacturing and distributing restrictions, under international treaties, on certain drug substances. The comments received in response to this notice and/ or public meeting will be considered in preparing the United States' position on these proposals for a meeting of the United Nations Commission on Narcotic Drugs (CND) in Vienna, Austria, in March 2016. This notice is issued under the Controlled Substances Act (the CSA).

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices''. FDA is issuing this draft guidance to assist industry and FDA staff in identifying specific considerations related to the ability of electronic medical devices to safely and effectively exchange and use exchanged information. This document highlights considerations that should be included in the development and design of interoperable medical devices and provides recommendations for the content of premarket submissions and labeling for such devices. This draft guidance is not final nor is it in effect at this time.

The Centers for Disease Control and Prevention (CDC), within the Department of Health and Human Services (HHS), is issuing this final rule (FR) to amend its regulations governing medical examinations that aliens must undergo before they may be admitted to the United States. Based on public comment received, HHS/CDC did not make changes from the NPRM published on June 23, 2015. Accordingly, this FR will: Revise the definition of communicable disease of public health significance by removing chancroid, granuloma inguinale, and lymphogranuloma venereum as inadmissible health-related conditions for aliens seeking admission to the United States; update the notification of the health-related grounds of inadmissibility to include proof of vaccinations to align with existing requirements established by the Immigration and Nationality Act (INA); revise the definitions and evaluation criteria for mental disorders, drug abuse and drug addiction; clarify and revise the evaluation requirements for tuberculosis; clarify and revise the process for the HHS/CDC-appointed medical review board that convenes to reexamine the determination of a Class A medical condition based on an appeal; and update the titles and designations of federal agencies within the text of the regulation.

AHRQ coordinates the development of sets of common definitions and reporting formats (Common Formats) for reporting on health care quality and patient safety. In order to support the Common Formats, AHRQ has provided technical specifications to promote standardization by ensuring that data collected by Patient Safety Organizations (PSOs) and other entities are clinically and electronically comparable. More information on the Common Formats, including the technical specifications, can be obtained through AHRQ's PSO Web site: https:// www.pso.ahrq.gov/. The purpose of this notice is to announce a meeting to discuss the Common Formats. This meeting is designed as an interactive forum where software developers and PSOs can provide input on the formats. AHRQ especially requests participation by and input from those entities which have used AHRQ's technical specifications and implemented, or plan to implement, the formats electronically.

This notice provides an update of the Department of Health and Human Services (HHS) poverty guidelines to account for last calendar year's increase in prices as measured by the Consumer Price Index.

The Administration for Children and Families (ACF), Administration on Children, Youth and Families (ACYF), Family and Youth Services Bureau's (FYSB), Runaway and Homeless Youth Program, announces the award of $200,000 as a single-source expansion supplement grant to PathWays PA to support activities and services for homeless youth under the TLP grant in Philadelphia, PA.

The Administration for Children and Families (ACF), Office of Refugee Resettlement (ORR), announces the award of a single-source program expansion supplement grant for $500,000. The expansion supplement grant will support the need to increase home study capacity to expedite completion of home studies for approximately 400 UCs. BCFS provides nationwide coverage of home study services to children in the care and custody of ORR, as well as services to include counseling, case management, and additional support services to the family or to the UC and their sponsor when a UC is released from ORR's care and custody.

The Administration for Children and Families (ACF), Administration on Children, Youth and Families (ACYF), Family and Youth Services Bureau (FYSB), Division of Family Violence and Prevention Services (DFVPS), announces the award of $175,000 as a single-source program expansion supplement grant to the Asian & Pacific Islander American Health Forum. The grantee, funded under the Family Violence Protection and Services Act (FVPSA) program, is a technical assistance (TA) provider that assists FVPSA service providers to build the capacity of domestic violence programs.

The Administration for Children and Families (ACF), Administration on Children, Youth and Families (ACYF), Family and Youth Services Bureau (FYSB), Division of Family Violence and Prevention Services (DFVPS) announces the award of $125,000 as a single-source program expansion supplement to the Casa de Esperanza in St. Paul, MN. The grantee, funded under the Family Violence Protection and Services Act (FVPSA) program, is a national technical assistance (TA) provider that assists FVPSA service providers to build the capacity of domestic violence programs to respond to the complex and diverse needs of survivors of domestic violence and dating violence from Latino communities.

The Food and Drug Administration (FDA or we) is correcting a final rule that published in the Federal Register of September 17, 2015. That final rule amended our regulation for current good manufacturing practice in manufacturing, packing, or holding human food to modernize it, and to add requirements for domestic and foreign facilities that are required to register under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to establish and implement hazard analysis and risk-based preventive controls for human food. That final rule also revised certain definitions in our current regulation for registration of food facilities to clarify the scope of the exemption from registration requirements provided by the FD&C Act for ``farms.'' The final rule published with some editorial and inadvertent errors. This document corrects those errors.

The Food and Drug Administration (FDA or we) is amending a final rule that published in the Federal Register of September 17, 2015. That final rule established requirements for domestic and foreign facilities required to register under the Federal Food, Drug, and Cosmetic Act for current good manufacturing practice, hazard analysis, and risk-based preventive controls for food for animals. The final rule published with some editorial and inadvertent errors. This document corrects those errors.

In the Federal Register of November 18, 2015 (80 FR 71990), the Food and Drug Administration (FDA) published a proposed rule entitled, ``Food Labeling; Gluten-Free Labeling of Fermented or Hydrolyzed Foods.'' Due to an inadvertent error, the publication contained conflicting dates for submission of comments under the Paperwork Reduction Act of 1995. This notice corrects that error.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Postmarket Management of Cybersecurity in Medical Devices.'' This draft guidance informs industry and FDA staff of the Agency's recommendations for identifying, addressing, and monitoring cybersecurity vulnerabilities and exploits for postmarket management of medical devices. This draft guidance is neither final nor is it in effect at this time.

The Health Resources and Services Administration (HRSA) is requesting nominations to fill vacancies on the Advisory Committee on Organ Transplantation (ACOT). The ACOT was established by the Amended Final Rule of the Organ Procurement and Transplantation Network (OPTN) (42 CFR part 121) and, in accordance with Public Law 92-463, was chartered on September 1, 2000.

The Food and Drug Administration (FDA) is providing notice that the conditional approval of an application for masitinib mesylate tablets, a new animal drug for a minor use, is no longer in effect.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements.

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Implanted Blood Access Devices for Hemodialysis.'' This guidance was developed to support the reclassification of the implanted blood access devices for hemodialysis into class II (special controls) and to assist industry in preparing premarket notification (510(k)) submissions for implanted blood access devices for hemodialysis.

The Food and Drug Administration (FDA) is classifying the tympanic membrane contact hearing aid into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the tympanic membrane contact hearing aid's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

The Office for Human Research Protections (OHRP), a program office in the Office of the Assistant Secretary for Health, Department of Health and Human Services (HHS), is seeking four (4) nominations of qualified candidates to be considered for appointment as members of the Secretary's Advisory Committee on Human Research Protections (SACHRP). SACHRP provides advice and recommendations to the Secretary, HHS, through the Assistant Secretary for Health on issues pertaining to the continuance and improvement of functions within the authority of HHS directed toward protections for human subjects in research. SACHRP was established by the Secretary, HHS, on October 1, 2002. OHRP is seeking nominations of four qualified candidates to fill positions on the Committee membership that will be vacated during the 2016 calendar year, including the position of Chair.

The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a newly proposed information collection project entitled ``Monitoring and Coordinating Personal Protective Equipment (PPE) in Healthcare to Enhance Domestic Preparedness for Ebola Response''. The development of an ongoing Personal Protective Technology (PPT) sentinel surveillance system in the hospital setting will document data used to evaluate and monitor use and effectiveness for PPE usage in healthcare workers including Ebola protection.

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 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.

The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on the proposed revision of the information collection entitled ``Division of Community Health (DCH) Training and Technical Assistance: Needs Assessment and Satisfaction Surveys''.

The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on the Behavioral Risk Factor Surveillance System (BRFSS), a state-level survey of health risk behaviors and chronic health conditions. Survey questions are updated each year. The information collection is being revised to incorporate an annual field test of proposed changes prior to their implementation on a broad scale.

The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on the proposed information collect project entitled ``The Pregnancy Risk Assessment Surveillance System''.

This document contains technical amendments to HHS regulations regarding Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards. The regulatory content is being amended to add information that was erroneously omitted, to include updated cross-references within HHS' regulations, and to make grammatical corrections.

The National Institute for Occupational Safety and Health (NIOSH), part of the Centers for Disease Control and Prevention (CDC), requests information to enhance the value of the NIOSH Center for Direct Reading and Sensor Technologies and is seeking input regarding specific issues on the availability, capability, suitability, barriers, limitations, and opportunities for current or future direct reading devices and sensor technologies that can be utilized for emergency response. This RFI is intended to inform the planning of a document to evaluate current and future sensor technologies used in emergency response.

The Food and Drug Administration (FDA) is requesting any industry organizations interested in participating in the selection of voting industry representatives to serve on the Technical Electronic Product Radiation Safety Standards Committee for the Center for Devices and Radiological Health to notify FDA in writing. FDA is also requesting nominations for voting industry representatives to serve on the Technical Electronic Product Radiation Safety Standards Committee. A nominee may either be self-nominated or nominated by an organization to serve as a voting industry representative. Nominations will be accepted for current vacancies effective with this notice.

The Pill Image Recognition Challenge is a National Institutes of Health (NIH) Challenge under the America COMPETES (Creating Opportunities to Meaningfully Promote Excellence in Technology, Education, and Science) Reauthorization Act of 2010 (Pub. L. 111-358). Through this Challenge, the National Library of Medicine (NLM), part of NIH, seeks algorithms and software to match images of prescription oral solid-dose pharmaceutical medications (pills, including capsules and tablets). The objective of the Challenge is the development and discovery of high-quality algorithms and software that rank how well consumer images of prescription pills match reference images of pills in the authoritative NLM RxIMAGE database. NLM may use all or part of any Challenge entry (i.e., algorithm and software) to create a future software system and a future API (Application Programming Interface) for pill image recognition; the system will be freely usable and the API will be freely accessible.

The Food and Drug Administrations (FDA) Center for Drug Evaluation and Research (CDER), is sponsoring a public workshop entitled ``Navigating CDER: What You Should Know for Effective Engagement.'' The purpose of this public workshop is to help the public and patient advocacy groups gain a better understanding of how to effectively engage CDER.

The Food and Drug Administration (FDA) is announcing a public conference entitled ``How Should Liver Injury and Dysfunction Caused by Drugs Be Measured, Evaluated, and Acted Upon in Clinical Trials?'' This conference will be cosponsored with the Critical Path Institute (C- Path). The purpose of the conference is to discuss, debate, and share views among stakeholders in academia, patient groups, regulatory bodies, and the health care and pharmaceutical industries on how best to measure, evaluate, and act upon liver injury and dysfunction caused by drugs used during clinical trials.

This final rule makes regulatory changes to the Temporary Assistance for Needy Families (TANF) regulations to require states, subject to penalty, to maintain policies and practices that prevent TANF funded assistance from being used in any electronic benefit transfer transaction in any liquor store; any casino, gambling casino, or gaming establishment; or any retail establishment that provides adult-oriented entertainment in which performers disrobe or perform in an unclothed state for entertainment. This rule implements provisions of Section 4004 of the Middle Class Tax Relief and Job Creation Act of 2012.

The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on the proposed information collection entitled ``Young Men who have Sex with Men (YMSM) Study Thailand''. CDC is requesting a three-year approval for this new project.

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 Cancer Institute, the 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 to address 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) The quality, utility, and clarity of the information to be collected; and (4) 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*: Rebecca Ferrer, Program Director, Basic Biobehavioral and Psychological Sciences Branch, Behavioral Research Program, Division of Cancer Control and Population Sciences, National Cancer Institute, 9609 Medical Center Dr., Rockville MD 20852. or call non-toll-free number (240) 276-6914 or Email your request, including your address to: ferrerra@mail.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: Self-affirmation Construct Validity, 0925-NEW, National Cancer Institute (NCI), National Institutes of Health (NIH). Need and Use of Information Collection: This information collection, seeks to refine a theory about how self-competence and values play a role in defensive responses to health communications. Although theoretically-driven research has shown that self- affirmationa process by which individuals reflect on values that are important to themcan improve responses to health and cancer communications, the ``active ingredient'' (or mechanisms underlying effectiveness) of self-affirmations is unknown. Self-affirmation is a potent means of augmenting the effectiveness of threatening health communications. Individuals tend to be defensive against information suggesting their behavior puts them at risk for disease or negative health. Previous evidence suggests that self-affirmation may reduce defensiveness to threatening health information, increasing openness to the message and resulting in increased disease risk perceptions, disease-related worry, intentions to engage in preventive behavior, and actual behavioral change. Understanding the mechanisms that explain these robust effects would yield evidence important for dissemination, including ways to refine self-affirmation interventions and make them more potent, which could change the ways that public health messages are constructed. This research can inform NCI scientific priorities and investments in self-affirmation research. The results of the information collection will be used to further develop and improve self-affirmation theory. These findings may allow future researchers to develop and test cancer prevention interventions. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 717.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a document entitled ``Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products; Guidance for Industry.'' The guidance document provides blood collecting establishments and manufacturers of plasma derivatives with comprehensive recommendations intended to minimize the possible risk of transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) from blood and blood products. The guidance amends the guidance document entitled ``Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products'' dated May 2010 (2010 guidance) by finalizing and incorporating the recommendations from the draft document entitled ``Draft Guidance for Industry: Amendment to 'Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products''' dated June 2012 (2012 draft guidance).

This notice announces the first meeting date for the Physician-Focused Payment Model Technical Advisory Committee (hereafter referred to as ``the Committee'') on Monday, February 1, 2016.

The National Center for Advancing Translational Sciences (NCATS) is extending the comment period for responses to its Request for Information (RFI), published in Vol. 80, No. 195, of the Federal Register on October 8, 2015. The response date has been extended from January 8, 2016, to February 8, 2016, to provide additional time for any and all interested parties to respond to this RFI. Comments must be submitted electronically using the web-based form available at https:// grants.nih.gov/grants/rfi/rfi.cfm?ID=50.

In compliance with the requirement for opportunity for public comment on proposed data collection projects (Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995), the Health Resources and Services Administration (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 (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 regulations restricting the sale and distribution of cigarettes and smokeless tobacco to protect children and adolescents.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document entitled ``Use of Nucleic Acid Tests to Reduce the Risk of Transmission of Hepatitis B Virus from Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry.'' The draft guidance document provides establishments that make donor eligibility determinations for donors of human cells, tissues, and tissue-based products (HCT/Ps), with recommendations concerning the use of FDA-licensed nucleic acid tests (NAT) in donor testing for hepatitis B virus (HBV) deoxyribonucleic acid (DNA). The draft guidance, when finalized, is intended to supplement previous FDA recommendations to HCT/P establishments concerning donor testing for hepatitis B surface antigen (HBsAg) and total antibody to hepatitis B core antigen (anti-HBc), in the document entitled ``Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/ Ps)'' dated August 2007 (2007 Donor Eligibility Guidance).