Department of Health and Human Services January 2016 – Federal Register Recent Federal Regulation Documents
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Agency Information Collection Activities: Submission for OMB Review; Comment Request
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.
Agency Information Collection Activities: Proposed Collection; Comment Request
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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Public Health Service Guideline on Infectious Disease Issues in Xenotransplantation
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.
Public Notification of Emerging Postmarket Medical Device Signals ('Emerging Signals'); Draft Guidance for Industry and Food and Drug Administration Staff; Extension of Comment Period
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.
HHS-Operated Risk Adjustment Methodology Meeting; March 31, 2016
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.
Submission of OMB Review, 30-Day Comment Request; Conference, Meeting, Workshop, and Poster Session Registration Generic Clearance (OD)
Under the provisions of Section 3507(a)(1)(D) of 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. This proposed information collection was previously published in the Federal Register on July 30, 2015, page 45541 and allowed 60-day for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health (NIH), Office of the Director (OD), 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 items(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.
Request for Nominations on the National Mammography Quality Assurance Advisory Committee
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.
Food and Drug Administration/Xavier University PharmaLink Conference: Increasing Product Confidence
The Food and Drug Administration (FDA) Cincinnati District, in co-sponsorship with Xavier University, is announcing a public conference entitled ``FDA/Xavier University PharmaLink Conference: Increasing Product Confidence''. The PharmaLink conference seeks solutions to important and complicated issues by aligning with the strategic priorities of FDA, featuring presentations from key FDA officials, global regulators, and industry experts. Each presentation challenges the status quo and conventional wisdom, to create synergies focused on finding solutions which make a difference. The experience level of the audience has fostered engaged dialogue, which has led to innovative initiatives.
International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; World Health Organization; Scheduling Recommendations; Acetylfentanyl; MT-45; para-Methoxymethylamphetamine (PMMA); α-Pyrrolidinovalerophenone (α-PVP); para-Methyl-4-methylaminorex (4,4′-DMAR); Methoxetamine (MXE); Phenazepam; Request for Comments
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).
Determination That IZBA (Travoprost Ophthalmic Solution), 0.003 Percent, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA or Agency) has determined that IZBA (travoprost ophthalmic solution), 0.003 percent, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for travoprost ophthalmic solution/drops, 0.003 percent, if all other legal and regulatory requirements are met.
Design Considerations and Premarket Submission Recommendations for Interoperable Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
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.
Medical Examination of Aliens-Revisions to Medical Screening Process
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.
Notice of Meetings
The subcommittees listed below are part of AHRQ's Health Services Research Initial Review Group Committee. Grant applications are to be reviewed and discussed at these meetings. Each subcommittee meeting will commence in open session before closing to the public for the duration of the meeting. These meetings will be closed to the public in accordance with 5 U.S.C. App. 2 section 10(d), 5 U.S.C. 552b(c)(4), and 5 U.S.C. 552b(c)(6).
Meeting for Software Developers on the Common Formats for Patient Safety Data Collection and Event Reporting
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.
Catastrophic Health Emergency Fund
The Indian Health Service (IHS) administers the Catastrophic Health Emergency Fund, The purpose of CHEF is to meet the extraordinary medical costs associated with the treatment of victims of disasters or catastrophic illnesses who are within the responsibility of the Service. This proposed rule: Proposes definitions governing the CHEF; establishes that a Service Unit shall not be eligible for reimbursement for the cost of treatment until the episode of care's cost has reached a certain threshold; establishes a procedure for reimbursement for certain services exceeding a threshold cost; establishes a procedure for payment for certain cases; and, establishes a procedure to ensure payment will not be made from CHEF if other sources of payment (Federal, state, local, private) are available.
Annual Update of the HHS Poverty Guidelines
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.
Submission for OMB Review; 30-Day Comment Request; Media-Smart Youth Leaders Program
Under the provisions of section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, 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. This proposed information collection was previously published in the Federal Register on October 16, 2015, pages 62541-62542, and allowed 60 days for public comment. One public comment was received. The purpose of this notice is to allow an additional 30 days for public comment. The Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, 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.
Announcement of the Award of a Single-Source Expansion Supplement Grant to PathWays PA in Philadelphia, PA
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.
Announcement of the Award of a Single-Source Expansion Supplement Grant to the National Runaway Switchboard
The Administration for Children and Families (ACF), Administration on Children, Youth and Families (ACYF), Family and Youth Services Bureau (FYSB), Division of Adolescent Development and Support (DADS), announces the award of a single-source expansion supplement grant of $34,000 to the National Runaway Switchboard to support research and the translation of ``Let's Talk Curriculum'' into Spanish and disseminate it to culturally appropriate prevention resources to expand outreach to Latino youth and their families.
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