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

Results 201 - 250 of 347
Notice of Meeting
Document Number: 2016-02775
Type: Notice
Date: 2016-02-11
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Advisory Committee for Women's Services (ACWS); Notice of Meeting
Document Number: 2016-02774
Type: Notice
Date: 2016-02-11
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Notice of Meeting
Document Number: 2016-02773
Type: Notice
Date: 2016-02-11
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
30-Day-16-15BHD]
Document Number: 2016-02765
Type: Notice
Date: 2016-02-11
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of Closed Meetings
Document Number: 2016-02712
Type: Notice
Date: 2016-02-11
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2016-02711
Type: Notice
Date: 2016-02-11
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2016-02710
Type: Notice
Date: 2016-02-11
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Biomedical Imaging and Bioengineering; Notice of Closed Meetings
Document Number: 2016-02709
Type: Notice
Date: 2016-02-11
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2016-02708
Type: Notice
Date: 2016-02-11
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meetings
Document Number: 2016-02707
Type: Notice
Date: 2016-02-11
Agency: Department of Health and Human Services
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2016-02706
Type: Notice
Date: 2016-02-11
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2016-02705
Type: Notice
Date: 2016-02-11
Agency: Department of Health and Human Services, National Institutes of Health
Workshop on Shift Work at Night, Artificial Light at Night, and Circadian Disruption; Notice of Public Meeting; Registration Information
Document Number: 2016-02703
Type: Notice
Date: 2016-02-11
Agency: Department of Health and Human Services, National Institutes of Health
The National Toxicology Program (NTP) announces the public workshop ``Shift Work at Night, Artificial Light at Night, and Circadian Disruption.'' The purpose of the workshop is to obtain external scientific input on topics important for informing the literature-based health hazard assessments conducted by the NTP's Office of the Report on Carcinogens (ORoC) and Office of Health Assessment and Translation (OHAT). This workshop is open to the public to attend in-person or by webcast. Information about the meeting and registration are available at (http://ntp.niehs.nih.gov/go/ workshop_ALAN).
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2016-02686
Type: Notice
Date: 2016-02-10
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.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2016-02685
Type: Notice
Date: 2016-02-10
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 (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.
Request for Measures Assessing Health Care Organization Quality Improvement Activities To Improve Patient Understanding, Navigation, Engagement, and Self-Management
Document Number: 2016-02679
Type: Notice
Date: 2016-02-10
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
The Agency for Healthcare Research and Quality (AHRQ) requests information from the public (including health care delivery organizations, health information developers, payers, quality measure developers, clinicians, and health care consumers) about quality improvement measures designed to help health care organizations monitor initiatives aimed at: Improving patient understanding of health information, simplifying navigation of health care systems and facilities, and enhancing patients' ability to manage their health. Specifically, AHRQ seeks quality improvement measures in four domains: 1. Communication, 2. Ease of Navigation, 3. Patient Engagement and Self-Management, and 4. Organizational Structure, Policy, and Leadership. AHRQ is interested in measures that do not require patient survey data and that health care organizations are currently using, or have used in the past, to guide quality improvement activities designed to address these domains. AHRQ is also interested in information about relevant measures that are under development or are suggested for future development.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2016-02678
Type: Notice
Date: 2016-02-10
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Making It Easier for Patients to Understand Health Information and Navigate Health Care Systems: Developing Quality Improvement Measures.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection.
Draft Criteria for a Recommended Standard: Occupational Exposure to 1-Bromopropane (1-BP); Notice of Public Meeting; Availability of Draft Document for Comment
Document Number: 2016-02650
Type: Notice
Date: 2016-02-10
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
On September 16, 2009, the National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention (CDC) announced in the Federal Register https://www.gpo.gov/fdsys/pkg/ FR-2009-09-16/pdf/E9-22297.pdf plans to evaluate the scientific data on 1-bromopropane (1-BP) and to issue its findings on the potential health risks. A draft document entitled, Criteria for a Recommended Standard: Occupational Exposure to 1-Bromopropane (1-BP), has been developed which contains an assessment of toxicological data and provides recommendations for the safe handling of 1-BP-containing materials. NIOSH is seeking comments on the draft document and plans to have a public meeting to discuss the document. The draft document and instructions for submitting comments can be found at www.regulations.gov.
Closed-Circuit Escape Respirators; Approval of Cap 3 Device for Underground Coal Mining
Document Number: 2016-02649
Type: Notice
Date: 2016-02-10
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The National Institute for Occupational Safety and Health (NIOSH) and the Mine Safety and Health Administration (MSHA) have approved the first large-capacity (Cap 3) closed-circuit escape respirator (CCER) for use in underground coal mining, under the NIOSH new regulatory standard. Accordingly, respirator manufacturers may continue to manufacture, label, and sell large-capacity CCERs approved under the former regulatory standard (those CCERs with a rated service time of greater than 50 minutes) for underground coal mining approved under the former regulatory standard until January 4, 2017.
Draft Current Intelligence Bulletin: Health Effects of Occupational Exposure to Silver Nanomaterials; Notice of Public Meeting; Availability of Document for Comment; Extension of Comment Period
Document Number: 2016-02647
Type: Notice
Date: 2016-02-10
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
On January 21, 2016, the Director of the National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC), published a notice in the Federal Register [81 FR 3425] announcing the availability of the following draft document for public comment entitled Draft Current Intelligence Bulletin: Health Effects of Occupational Exposure to Silver Nanomaterials. Written comments were to be received by March 21, 2016. NIOSH is extending the public comment period until April 22, 2016.
Submission for OMB Review; Comment Request
Document Number: 2016-02629
Type: Notice
Date: 2016-02-10
Agency: Department of Health and Human Services, Administration for Children and Families
Proposed Information Collection Activity; Comment Request
Document Number: 2016-02625
Type: Notice
Date: 2016-02-10
Agency: Department of Health and Human Services, Administration for Children and Families
Meeting of the Community Preventive Services Task Force (Task Force)
Document Number: 2016-02619
Type: Notice
Date: 2016-02-10
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services announces the next meeting of the Community Preventive Services Task Force (Task Force). The Task Force is an independent, nonpartisan, nonfederal, and unpaid panel. Its members represent a broad range of research, practice, and policy expertise in prevention, wellness, health promotion, and public health, and are appointed by the CDC Director. The Task Force was convened in 1996 by the Department of Health and Human Services (HHS) to identify population health interventions that are scientifically proven to save lives, increase lifespans, and improve quality of life. CDC is mandated to provide ongoing administrative, research, and technical support for the operations of the Task Force. During its meetings, the Task Force (a) considers the findings of systematic reviews that assess the effectiveness and economics of community preventive services, programs, and policies, and (b) issues recommendations. Task Force recommendations are not mandates for compliance or spending. Instead, they provide information about evidence-based options that decision makers and stakeholders can consider when determining what best meets the specific needs, preferences, available resources, and constraints of their jurisdictions and constituents. The Task Force's recommendations, along with the systematic reviews of the scientific evidence on which they are based, are compiled in the Guide to Community Preventive Services (The Community Guide).
Advancing the Development of Biomarkers in Traumatic Brain Injury; Public Workshop; Request for Comments
Document Number: 2016-02592
Type: Notice
Date: 2016-02-10
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the following public workshop entitled, ``Advancing the Development of Biomarkers in Traumatic Brain Injury.'' This workshop aims to examine potential biomarkers, discuss the challenges and solutions related to biomarker development methodologies, and establish strategies for data standardization, sharing and analysis of big data sets for traumatic brain injury (TBI). By convening the relevant stakeholders, the goal is to obtain input on the scientific, clinical, patient, and regulatory considerations associated with TBI biomarker development to improve diagnosis and clinical utility for TBI.
Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review
Document Number: 2016-02582
Type: Notice
Date: 2016-02-10
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2016-02581
Type: Notice
Date: 2016-02-10
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review
Document Number: 2016-02575
Type: Notice
Date: 2016-02-10
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Center for Substance Abuse Prevention; Notice of Meeting
Document Number: 2016-02573
Type: Notice
Date: 2016-02-10
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Advisory Council on Blood Stem Cell Transplantation; Notice of Meeting
Document Number: 2016-02572
Type: Notice
Date: 2016-02-10
Agency: Department of Health and Human Services, Health Resources and Services Administration
Agency Information Collection Activities: Proposed Collection: Public Comment Request
Document Number: 2016-02571
Type: Notice
Date: 2016-02-10
Agency: Department of Health and Human Services, Health Resources and Services Administration
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.
Tribal Consultation Meetings
Document Number: 2016-02580
Type: Notice
Date: 2016-02-09
Agency: Department of Health and Human Services, Administration for Children and Families
Pursuant to the Improving Head Start for School Readiness Act of 2007, Public Law 110-134, notice is hereby given of three 1-day Tribal Consultation Sessions to be held between the Department of Health and Human Services (HHS), Administration for Children and Families, OHS leadership and the leadership of Tribal Governments operating Head Start (including Early Head Start) programs. The purpose of these Consultation Sessions is to discuss ways to better meet the needs of American Indian and Alaska Native children and their families, taking into consideration funding allocations, distribution formulas, and other issues affecting the delivery of Head Start services in their geographic locations [42 U.S.C. 9835, section 640(l)(4)].
The Use of Chimpanzees in NIH-Supported Research
Document Number: 2016-02554
Type: Notice
Date: 2016-02-09
Agency: Department of Health and Human Services, National Institutes of Health
This notice provides information on the National Institutes of Health's (NIH) reassessment of the need to maintain a colony of 50 chimpanzees for future research and decision to no longer maintain a chimpanzee colony for research. This notice also provides information on conforming updates and procedures related to this action.
Independent Assessment of the Process for the Review of Device Submissions; Implementation Evaluation Report
Document Number: 2016-02545
Type: Notice
Date: 2016-02-09
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing Booz Allen Hamilton's final evaluation report submitted as part of their independent assessment of the process for the review of medical device submissions. The evaluation is part of the FDA performance commitments relating to the Medical Device User Fee Amendments of 2012 (MDUFA III), which reauthorized device user fees for fiscal years 2013 through 2017. The assessment is described in section V, Independent Assessment of Review Process Management, of the commitment letter entitled ``MDUFA Performance Goals and Procedures'' (MDUFA III Commitment Letter). The evaluation has been conducted as the second phase (Phase 2) and is the last of a series of deliverables, as outlined in the contract statement of work.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2016-02540
Type: Notice
Date: 2016-02-09
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meetings
Document Number: 2016-02539
Type: Notice
Date: 2016-02-09
Agency: Department of Health and Human Services
National Human Genome Research Institute; Notice of Closed Meetings
Document Number: 2016-02538
Type: Notice
Date: 2016-02-09
Agency: Department of Health and Human Services, National Institutes of Health
National Human Genome Research Institute; Notice of Closed Meeting
Document Number: 2016-02537
Type: Notice
Date: 2016-02-09
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Neurological Disorders and Stroke; Notice of Closed Meetings
Document Number: 2016-02536
Type: Notice
Date: 2016-02-09
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2016-02535
Type: Notice
Date: 2016-02-09
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meetings
Document Number: 2016-02534
Type: Notice
Date: 2016-02-09
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2016-02533
Type: Notice
Date: 2016-02-09
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2016-02532
Type: Notice
Date: 2016-02-09
Agency: Department of Health and Human Services, National Institutes of Health
Privacy Act of 1974
Document Number: 2016-02527
Type: Notice
Date: 2016-02-09
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
In accordance with the requirements of the Privacy Act of 1974, as amended, this notice announces the re-establishment of a CMP that CMS plans to conduct with the Social Security Administration (SSA).
Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications
Document Number: 2016-02522
Type: Notice
Date: 2016-02-09
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is publishing a list of premarket approval applications (PMAs) that have been approved. This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the Internet and the Agency's Division of Dockets Management.
Display Devices for Diagnostic Radiology; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2016-02521
Type: Notice
Date: 2016-02-09
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 ``Display Devices for Diagnostic Radiology''. This draft guidance document provides recommendations for the types of information you should provide in your premarket notification submission (510(k)) for display devices intended for diagnostic radiology with the assigned product code PGY. This guidance, when finalized, will replace a previously issued final guidance entitled ``Display Accessories for Full-Field Digital Mammography Systems-Premarket Notification (510(k)) Submissions,'' issued on May 30, 2008. This draft guidance is not final nor is it in effect at this time.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2016-02519
Type: Notice
Date: 2016-02-09
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Recommendations for Premarket Notifications for Lamotrigine and Zonisamide Assays; Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2016-02516
Type: Notice
Date: 2016-02-09
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Recommendations for Premarket Notifications for Lamotrigine and Zonisamide Assays.'' This guidance document discusses information to be included in premarket notifications for zonisamide or lamotrigine assays.
Training Program for Regulatory Project Managers; Information Available to Industry
Document Number: 2016-02515
Type: Notice
Date: 2016-02-09
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration's (FDA's) Center for Drug Evaluation and Research (CDER) is announcing the continuation of the Regulatory Project Management Site Tours and Regulatory Interaction Program (the Site Tours Program). The purpose of this document is to invite pharmaceutical companies interested in participating in this program to contact CDER.
Advisory Committee to the Director (ACD), Centers for Disease Control and Prevention (CDC): Notice of Charter Renewal
Document Number: 2016-02480
Type: Notice
Date: 2016-02-09
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services