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

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Document Number: 2016-02889
Type: Notice
Date: 2016-02-12
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Guidance for Industry on Formal Meetings With Sponsors and Applicants for Prescription Drug User Fee Act Products'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Document Number: 2016-02888
Type: Notice
Date: 2016-02-12
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 ``Manufactured Food Regulatory Program Standard.''
Document Number: 2016-02887
Type: Notice
Date: 2016-02-12
Agency: Food and Drug Administration, Department of Health and Human Services
The invention listed in this document is owned by an Agency of the U.S. Government and is available for licensing in accordance with Federal regulations to achieve expeditious commercialization of results of Federally funded research and development.
Document Number: 2016-02884
Type: Rule
Date: 2016-02-12
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is removing two regulations that prescribe procedures for FDA's review and classification of biological products licensed before July 1, 1972. FDA is taking this action because the two regulations are obsolete and no longer necessary in light of other statutory and regulatory authorities established since 1972, which allow FDA to evaluate and monitor the safety and effectiveness of all biological products. In addition, other statutory and regulatory authorities authorize FDA to revoke a license for biological products because they are not safe and effective, or are misbranded. FDA is taking this action as part of its retrospective review of its regulations to promote improvement and innovation.
Document Number: 2016-02882
Type: Notice
Date: 2016-02-12
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Request for Samples and Protocols'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Document Number: 2016-02881
Type: Notice
Date: 2016-02-12
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Document Number: 2016-02880
Type: Notice
Date: 2016-02-12
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Labeling of Certain Beers Subject to the Labeling Jurisdiction of the Food and Drug Administration'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Document Number: 2016-02879
Type: Notice
Date: 2016-02-12
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Characterization of Ultrahigh Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic Devices''. The guidance identifies the types of UHMWPE currently in use in orthopedic implants, as well as the recommended information and testing that should be included in premarket submissions for such devices. This draft guidance is not final nor is it in effect at this time.
Document Number: 2016-02878
Type: Rule
Date: 2016-02-12
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is classifying the scalp cooling system to reduce the likelihood of chemotherapy-induced alopecia 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 scalp cooling system to reduce the likelihood of chemotherapy-induced alopecia'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.
Document Number: 2016-02877
Type: Notice
Date: 2016-02-12
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration, in cosponsorship with the Pharmaceutical Users Software Exchange (PhUSE) is announcing a public conference entitled ``The FDA/PhUSE Annual Computational Science Symposium.'' The purpose of the conference is to help the broader community align and share experiences to advance computational science. At the conference, which will bring together FDA, industry, and academia, FDA will update participants on current initiatives, and collaborative project groups will address specific challenges in accessing and reviewing data to support product development. These project groups will focus on solutions and practical ways to implement them.
Document Number: 2016-02876
Type: Rule
Date: 2016-02-12
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is issuing a final order to redesignate membrane lung devices for long-term pulmonary support, a preamendments class III device, as extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure, and to reclassify the device to class II (special controls) in patients with acute respiratory failure or acute cardiopulmonary failure where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent. A membrane lung device for long-term pulmonary support (>6 hours) refers to the oxygenator in an extracorporeal circuit used during long-term procedures, commonly referred to as extracorporeal membrane oxygenation (ECMO). Because a number of other devices and accessories are used with the oxygenator in the circuit, the title and identification of the regulation are revised to include extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure. Although an individual device or accessory used in an ECMO circuit may already have its own classification regulation when the device or accessory is intended for short-term use (6 hours). On its own initiative, based on new information, FDA is revising the classification of the membrane lung device for long-term pulmonary support.
Document Number: 2016-02857
Type: Notice
Date: 2016-02-12
Agency: Food and Drug Administration, Department of Health and Human Services
Document Number: 2016-02853
Type: Notice
Date: 2016-02-12
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2016-02852
Type: Notice
Date: 2016-02-12
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2016-02851
Type: Notice
Date: 2016-02-12
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2016-02850
Type: Notice
Date: 2016-02-12
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2016-02849
Type: Notice
Date: 2016-02-12
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2016-02848
Type: Notice
Date: 2016-02-12
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2016-02789
Type: Rule
Date: 2016-02-12
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final rule requires providers and suppliers receiving funds under the Medicare program to report and return overpayments by the later of the date that is 60 days after the date on which the overpayment was identified; or the date any corresponding cost report is due, if applicable. The requirements in this rule are meant to ensure compliance with applicable statutes, promote the furnishing of high quality care, and to protect the Medicare Trust Funds against fraud and improper payments. This rule provides needed clarity and consistency in the reporting and returning of self-identified overpayments.
Document Number: 2016-02809
Type: Notice
Date: 2016-02-11
Agency: Department of Health and Human Services, National Institutes of Health
The Kidney Interagency Coordinating Committee (KICC) will hold a meeting on March 11, 2016, on the programmatic implications of the United States Renal Data System (USRDS) to federal agencies. The meeting is open to the public.
Document Number: 2016-02798
Type: Notice
Date: 2016-02-11
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces seven new membership appointments to the Advisory Panel on Hospital Outpatient Payment (the Panel). The seven new appointments to the Panel will each serve a 4-year period. The new members have terms that begin in Calendar Year (CY) 2016 and end in CY 2020. The purpose of the Panel is to advise the Secretary of the Department of Health and Human Services and the Administrator of the Centers for Medicare & Medicaid Services concerning the clinical integrity of the Ambulatory Payment Classification groups and their relative payment weights. The Panel also addresses and makes recommendations regarding supervision of hospital outpatient therapeutic services. The advice provided by the Panel will be considered as we prepare the annual updates for the hospital outpatient prospective payment system. The Secretary rechartered the Panel in 2014 for a 2-year period effective through November 6, 2016.
Document Number: 2016-02794
Type: Notice
Date: 2016-02-11
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Document Number: 2016-02786
Type: Notice
Date: 2016-02-11
Agency: Food and Drug Administration, Department of Health and Human Services
This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Pharmacy Compounding Advisory Committee (PCAC). General Function of the Committee: To provide advice on scientific, technical, and medical issues concerning drug compounding under sections 503A and 503B (21 U.S.C. 353A and 353B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), and, as required, any other product for which FDA has regulatory responsibility, and make appropriate recommendations to the Commissioner of Food and Drugs. Date and Time: The meeting will be held on March 8, 2016, from 8:30 a.m. to 4:30 p.m., and on March 9, 2016, from 8:30 a.m. to 1 p.m. Location: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (rm. 1503), Silver Spring, MD 20993- 0002. Answers to commonly asked questions including information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: http://www.fda.gov/ AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
Document Number: 2016-02784
Type: Notice
Date: 2016-02-11
Agency: Department of Health and Human Services, Administration for Children and Families
Statement of organization, functions, and delegations of authority. The Administration for Children and Families (ACF) has reorganized the Office of the Deputy Assistant Secretary for Early Childhood Development (ODAS-ECD) within the Office of the Assistant Secretary (OAS), the Office of Head Start (OHS), and the Office of Child Care (OCC). This reorganization will transfer reporting authority of OCC and OHS in their entirety from OAS to the ODAS-ECD. This reorganization creates within ODAS-ECD the Division of Policy and Budget; the Division of Comprehensive Services and Training and Technical Assistance; the Division of Research, Analysis, and Communications; and the Division of Interagency and Special Initiatives. Additionally, this reorganization will realign and combine several functions currently separately managed within OHS, OCC, and ODAS-ECD. The ODAS-ECD reviewed the programmatic and administrative similarities and differences between OHS and OCC and is proposing a new organizational structure that will not only retain the autonomy of the Head Start and Child Care programs and retain the best parts of how they provide services, but will also demonstrate a clear message to the field about the alignment of the Head Start and Child Care program offices, the unified focus of ensuring children receive quality services regardless of their program option, and a common message about the quality and expectations for services to children and families. Internally, the proposed reorganization will generate a more integrated alignment of standards through Head Start and Child Care programs, the development of a unified training and technical assistance system, consistent access to resources at the ACF level for both programs, and a shared use of research resources and agenda. Additionally, the proposed reorganization will result in greater collaborative efforts among both offices thereby leveraging best practices across both offices (monitoring, program outreach, content development, etc.). Moreover, both staffs will gain a broader understanding of the early childhood field and the inter-dependencies between programs. Within OHS, this reorganization eliminates the Education and Comprehensive Services Division and moves some of the functions to the newly created Division of Comprehensive Services and Training and Technical Assistance and the Division of Research, Analysis, and Communications within ODAS-ECD. It eliminates the Policy and Planning Division in OHS and moves some of those functions to the newly created Division of Policy and Budget within ODAS-ECD and to a new OHS Division of Planning, Oversight, and Policy. It eliminates the State Initiatives Division in OHS and moves some of those functions to each of the newly created Division of Interagency and Special Initiatives and the Division of Comprehensive Services and Training and Technical Assistance within ODAS-ECD. It also deletes the Grants and Contracts Division in OHS and moves the functions to two newly created and separate Divisions within OHSthe Division of Contracts and the Division of Grants. It combines the previous OHS Quality Assurance Division and OHS Policy and Planning Division to create the OHS Division of Planning, Oversight, and Policy. The OHS Program Operations Division remains the OHS Division of Program Operations. Within OCC, this reorganization eliminates the Division of Technical Assistance and moves most of its functions to the newly created Division of Comprehensive Services and Training and Technical Assistance within ODAS-ECD. It also eliminates the Division of Policy in OCC and moves some of those functions to the newly created Division of Policy and Budget within ODAS-ECD and to the new OCC Division of Planning, Data, and Policy. Within OCC, it creates a new Divisionthe Division of Oversight and Accountability. The OCC Division of Program Operations remains the Division of Program Operations. The goal of this reorganization is to more closely align early childhood programs, policies, and support functions in order to improve collaboration between OHS, OCC, and other federal agencies as appropriate. This will leverage best practices, generating more integrated and aligned standards through Head Start and Child Care, and improving access to ACF resources for OHS and OCC grantees while fully supporting the fundamental responsibility of operating Head Start and the Child Care and Development Fund to ensure the authorized purposes of each program and its funding are fully realized. This notice amends Part K of the Statement of Organization Functions, and Delegations of Authority of the Department of Health and Human Services, Administration for Children and Families: Chapter K, Administration for Children and Families, as last amended 77 FR 23250- 23260, April 18, 2012; Chapter KA, Office of the Assistant Secretary, as last amended 80 FR 33269-33270, June 11, 2015, and 75 FR 60471- 60473, September 30, 2010; Chapter KU, Office of Head Start (OHS), as last amended 75 FR 81280-81282, December 27, 2010; Chapter KV, Office of Child Care (OCC) as last amended 75 FR 60471-60473, September 30, 2010.
Document Number: 2016-02775
Type: Notice
Date: 2016-02-11
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Document Number: 2016-02774
Type: Notice
Date: 2016-02-11
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Document Number: 2016-02773
Type: Notice
Date: 2016-02-11
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Document Number: 2016-02765
Type: Notice
Date: 2016-02-11
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Document Number: 2016-02712
Type: Notice
Date: 2016-02-11
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2016-02711
Type: Notice
Date: 2016-02-11
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2016-02710
Type: Notice
Date: 2016-02-11
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2016-02709
Type: Notice
Date: 2016-02-11
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2016-02708
Type: Notice
Date: 2016-02-11
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2016-02707
Type: Notice
Date: 2016-02-11
Agency: Department of Health and Human Services
Document Number: 2016-02706
Type: Notice
Date: 2016-02-11
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2016-02705
Type: Notice
Date: 2016-02-11
Agency: Department of Health and Human Services, National Institutes of Health
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).
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.
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.
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.
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.
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.
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.
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.
Document Number: 2016-02629
Type: Notice
Date: 2016-02-10
Agency: Department of Health and Human Services, Administration for Children and Families
Document Number: 2016-02625
Type: Notice
Date: 2016-02-10
Agency: Department of Health and Human Services, Administration for Children and Families
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).
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.
Document Number: 2016-02582
Type: Notice
Date: 2016-02-10
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Document Number: 2016-02581
Type: Notice
Date: 2016-02-10
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
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