Department of Health and Human Services 2015 – Federal Register Recent Federal Regulation Documents

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Medicare Program; End-Stage Renal Disease Prospective Payment System, and Quality Incentive Program; Correction
Document Number: 2015-32967
Type: Rule
Date: 2015-12-31
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This document corrects technical and typographical errors that appeared in the final rule published in the Federal Register on November 6, 2015, entitled ``Medicare Program; End-Stage Renal Disease Prospective Payment System, and Quality Incentive Program.''
National Institute on Alcohol Abuse and Alcoholism; Notice of Meeting
Document Number: 2015-32941
Type: Notice
Date: 2015-12-31
Agency: Department of Health and Human Services, National Institutes of Health
Proposed Collection; 60 Day Comment Request; The Framingham Heart Study (NHLBI)
Document Number: 2015-32940
Type: Notice
Date: 2015-12-31
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Heart, Lung, and Blood Institute (NHLBI), the National Institutes of Health (NIH), will publish periodic summaries of proposed projects to the Office of Management and Budget (OMB) for review and approval. Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.
National Institute on Drug Abuse; Notice of Closed Meeting
Document Number: 2015-32939
Type: Notice
Date: 2015-12-31
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Meeting
Document Number: 2015-32938
Type: Notice
Date: 2015-12-31
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meeting
Document Number: 2015-32937
Type: Notice
Date: 2015-12-31
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Amended Notice of Meeting
Document Number: 2015-32936
Type: Notice
Date: 2015-12-31
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meetings
Document Number: 2015-32935
Type: Notice
Date: 2015-12-31
Agency: Department of Health and Human Services
Request for Information: Certification Frequency and Requirements for the Reporting of Quality Measures Under CMS Programs
Document Number: 2015-32931
Type: Notice
Date: 2015-12-31
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This request for information seeks public comment regarding several items related to the certification of health information technology (IT), including electronic health records (EHR) products used for reporting to certain CMS quality reporting programs such as, but not limited to, the Hospital Inpatient Quality Reporting (IQR) Program and the Physician Quality Reporting System (PQRS). In addition, we are requesting feedback on how often to require recertification, the number of clinical quality measures (CQMs) a certified Health IT Module should be required to certify to, and testing of certified Health IT Module(s).
Notice To Announce Commission of a Surgeon General's Report on Substance Use, Addiction, and Health
Document Number: 2015-32929
Type: Notice
Date: 2015-12-31
Agency: Department of Health and Human Services
On behalf of the United States Department of Health and Human Services, the Substance Abuse and Mental Health Services Administration and the Office of the Surgeon General announce the commission of the first-ever Surgeon General's Report presenting the state of the science on substance use, addiction, and health. The report will examine the health effects of drug and alcohol misuse from the perspectives of prevention, treatment, recovery, neurobiology, and delivery of care.
Center for Mental Health Services; Notice of Meeting
Document Number: 2015-32922
Type: Notice
Date: 2015-12-31
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Public Notification of Emerging Postmarket Medical Device Signals (“Emerging Signals”); Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2015-32920
Type: Notice
Date: 2015-12-31
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 ``Public Notification of Emerging Postmarket Medical Device Signals (`Emerging Signals').'' This guidance describes the Agency's policy for notifying the public about medical device ``emerging signals.'' Historically, FDA has communicated important medical device postmarket information after having completed an analysis of available data and, in most cases, after having reached a decision about relevant recommendations for the device user community and about whether further regulatory action is warranted. However, in addition to these types of public communications, we believe there also is a need to notify the public about emerging signals that the Agency is monitoring or analyzing, even when the information has not been fully analyzed, validated, or confirmed, and for which the Agency does not yet have specific recommendations. This draft guidance is not final nor is it in effect at this time.
Patient Safety Organizations: Voluntary Relinquishment from the Texas Patient Safety Organization, Inc.
Document Number: 2015-32914
Type: Notice
Date: 2015-12-31
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
The Patient Safety and Quality Improvement Act of 2005, 42 U.S.C. 299b-21 to b-26, (Patient Safety Act) and the related Patient Safety and Quality Improvement Final Rule, 42 CFR part 3 (Patient Safety Rule), published in the Federal Register on November 21, 2008, 73 FR 70732-70814, provide for the formation of Patient Safety Organizations (PSOs), which collect, aggregate, and analyze confidential information regarding the quality and safety of health care delivery. The Patient Safety Rule authorizes AHRQ, on behalf of the Secretary of HHS, to list as a PSO an entity that attests that it meets the statutory and regulatory requirements for listing. A PSO can be ``delisted'' by the Secretary if it is found to no longer meet the requirements of the Patient Safety Act and Patient Safety Rule, when a PSO chooses to voluntarily relinquish its status as a PSO for any reason, or when a PSO's listing expires. AHRQ has accepted a notification of voluntary relinquishment from the Texas Patient Safety Organization, Inc. of its status as a PSO, and has delisted the PSO accordingly. The Texas Patient Safety Organization, Inc. submitted this request for voluntary relinquishment during expedited revocation proceedings for cause.
National Institute of Allergy and Infectious Diseases; Closed Meeting
Document Number: 2015-32911
Type: Notice
Date: 2015-12-31
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings
Document Number: 2015-32910
Type: Notice
Date: 2015-12-31
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Complementary & Integrative Health; Notice of Closed Meeting
Document Number: 2015-32909
Type: Notice
Date: 2015-12-31
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2015-32880
Type: Notice
Date: 2015-12-31
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.
Advisory Council on Alzheimer's Research, Care, and Services; Meeting
Document Number: 2015-32890
Type: Notice
Date: 2015-12-30
Agency: Department of Health and Human Services
This notice announces the public meeting of the Advisory Council on Alzheimer's Research, Care, and Services (Advisory Council). The Advisory Council on Alzheimer's Research, Care, and Services provides advice on how to prevent or reduce the burden of Alzheimer's disease and related dementias on people with the disease and their caregivers. During the January meeting, the Advisory Council will review the process for developing recommendations and developing the National Plan to Address Alzheimer's Disease, discuss updates to work on Goals 2 and 3 of the National Plan, and hear updates on a future summit on care.
Government-Owned Inventions; Availability for Licensing
Document Number: 2015-32879
Type: Notice
Date: 2015-12-30
Agency: Department of Health and Human Services, National Institutes of Health
The invention listed below is owned by an agency of the U.S. Government and is available for licensing and/or co-development in the U.S. in accordance with 35 U.S.C. 209 and 37 CFR part 404 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing and/or co-development.
Government-Owned Inventions; Availability for Licensing and Co-Development
Document Number: 2015-32878
Type: Notice
Date: 2015-12-30
Agency: Department of Health and Human Services, National Institutes of Health
The invention listed below is owned by an agency of the U.S. Government and is available for licensing and/or co-development in the U.S. in accordance with 35 U.S.C. 209 and 37 CFR part 404 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing and/or co-development.
Government-Owned Inventions; Availability for Licensing
Document Number: 2015-32877
Type: Notice
Date: 2015-12-30
Agency: Department of Health and Human Services, National Institutes of Health
The invention listed below is owned by an agency of the U.S. Government and is available for licensing and/or co-development in the U.S. in accordance with 35 U.S.C. 209 and 37 CFR part 404 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing and/or co-development.
Acidified Foods; Draft Guidance for Industry; Withdrawal of Draft Guidance
Document Number: 2015-32781
Type: Notice
Date: 2015-12-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing the withdrawal of a draft guidance for industry, entitled ``Draft Guidance for Industry: Acidified Foods.'' The draft guidance was intended to complement our regulations regarding acidified foods (including regulations for specific current good manufacturing practice, establishment registration, and process filing) by helping commercial food processors determine whether their food products are subject to these regulations by providing for voluntary submission of process filings by processors of non-acidified foods (e.g., some acid foods or fermented foods), and by helping processors of acidified foods in ensuring safe manufacturing, processing, and packing processes and in employing appropriate quality control procedures. We are withdrawing the draft guidance, in part, because many of the topics addressed in the draft guidance are now being addressed in other documents.
National Institute on Aging; Notice of Closed Meeting
Document Number: 2015-32773
Type: Notice
Date: 2015-12-30
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2015-32772
Type: Notice
Date: 2015-12-30
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2015-32771
Type: Notice
Date: 2015-12-30
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2015-32770
Type: Notice
Date: 2015-12-30
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Biomedical Imaging and Bioengineering; Notice of Closed Meeting
Document Number: 2015-32769
Type: Notice
Date: 2015-12-30
Agency: Department of Health and Human Services, National Institutes of Health
Office of the Director; Amended Notice of Meeting
Document Number: 2015-32768
Type: Notice
Date: 2015-12-30
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2015-32767
Type: Notice
Date: 2015-12-30
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2015-32766
Type: Notice
Date: 2015-12-30
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Advancing Translational Sciences; Notice of Closed Meeting
Document Number: 2015-32765
Type: Notice
Date: 2015-12-30
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2015-32633
Type: Notice
Date: 2015-12-30
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.
Medicare Program; Prior Authorization Process for Certain Durable Medical Equipment, Prosthetics, Orthotics, and Supplies
Document Number: 2015-32506
Type: Rule
Date: 2015-12-30
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final rule establishes a prior authorization program for certain durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) items that are frequently subject to unnecessary utilization. This rule defines unnecessary utilization and creates a new requirement that claims for certain DMEPOS items must have an associated provisional affirmed prior authorization decision as a condition of payment. This rule also adds the review contractor's decision regarding prior authorization of coverage of DMEPOS items to the list of actions that are not initial determinations and therefore not appealable.
Proposed Action Under the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines)
Document Number: 2015-32810
Type: Notice
Date: 2015-12-29
Agency: Department of Health and Human Services, National Institutes of Health
The NIH is considering a proposal to conduct research involving the deliberate transfer of a chloramphenicol resistance trait to Rickettsia typhi, conorii, rickettsii, and felis. The acquisition of this antibiotic resistance trait could possibly compromise the use of a class of antibiotics for the treatment of Rickettsia infections in humans. Under the NIH Guidelines (http://www.osp.od.nih.gov/sites/ default/files/NIH_Guidelines.html), these experiments can proceed only after they are reviewed by the NIH Recombinant DNA Advisory Committee (RAC) and specifically approved by the NIH Director as Major Actions. This proposal will be discussed at the March 8-10, 2016 RAC meeting. The public is encouraged to provide comments on this proposed action.
Statement of Organization, Functions and Delegations of Authority
Document Number: 2015-32749
Type: Notice
Date: 2015-12-29
Agency: Department of Health and Human Services, Health Resources and Services Administration
Medical Device User Fee and Modernization Act; Notice to Public of Web Site Location of Fiscal Year 2016 Proposed Guidance Development
Document Number: 2015-32726
Type: Notice
Date: 2015-12-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is announcing the Web site location where the Agency will post two lists of guidance documents that the Center for Devices and Radiological Health (CDRH or the Center) intends to publish in Fiscal Year (FY) 2016. In addition, FDA has established a docket, where interested persons may comment on the priority of topics for guidance, provide comments and/or propose draft language for those topics, suggest topics for new or different guidance documents, comment on the applicability of guidance documents that have issued previously, and provide early input to support guidances that will be developed.
Establishment of a Public Docket; Clinical Trial Designs in Emerging Infectious Diseases
Document Number: 2015-32724
Type: Notice
Date: 2015-12-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is establishing a public docket to receive input on clinical trial designs in emerging infectious diseases. Interested parties are invited to submit comments, supported by research and data, regarding clinical trial designs.
Bioequivalence Recommendations for Paliperidone Palmitate; Draft Guidance for Industry; Availability
Document Number: 2015-32723
Type: Notice
Date: 2015-12-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a revised draft guidance for industry on paliperidone palmitate extended-release injectable suspension entitled ``Draft Guidance on Paliperidone Palmitate.'' The recommendations provide specific guidance on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for paliperidone palmitate extended-release injectable suspension.
Announcement of the Award of a Single-Source Expansion Supplement Grant to the Wisconsin Department for Children and Families in Madison, WI
Document Number: 2015-32702
Type: Notice
Date: 2015-12-29
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families (ACF), Office of Child Support Enforcement, Division of Program Innovation announces the award of a cooperative agreement in the amount of $700,000 to the Wisconsin Department for Children and Families in Madison, WI to support the evaluation of the Child Support Noncustodial Parent Employment Demonstration. In FY 2012, the Office of Child Support Enforcement (OCSE) competitively awarded a cooperative agreement to the Wisconsin Department of Children and Families to conduct a 5-year evaluation of OCSE's national demonstration called Child Support Noncustodial Parent Employment Demonstration (CSPED) under Funding Opportunity Announcement (FOA) number HHS-2012-ACF-OCSE-FD-0537. Under this FOA, a total of $4.5 million of 1115 funds were made available to the Wisconsin Department of Children and Families to conduct this evaluation. The award of $700,000 the Wisconsin Department of Children and Families is required to cover the unanticipated costs of conducting the CSPED evaluation. The CSPED evaluation includes an impact evaluation using random assignment, an implementation study and a benefit-cost analysis. The evaluator is also providing evaluation-related technical assistance to the grantees implementing CSPED. A baseline and 12 month follow-up survey are being conducted. Administrative data from multiple sources are also being collected and evaluated. A grants management information system was developed for grantees to use to conduct random assignment, enroll individuals into the project, and document service delivery.
Draft Guidances Relating to the Regulation of Human Cells, Tissues, or Cellular or Tissue-Based Products; Public Hearing; Request for Comments; Correction
Document Number: 2015-32686
Type: Proposed Rule
Date: 2015-12-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is correcting a notification of a public hearing entitled ``Draft Guidances Relating to the Regulation of Human Cells, Tissues, or Cellular or Tissue-Based Products; Public Hearing; Request for Comments'' that appeared in the Federal Register of October 30, 2015 (80 FR 66845). The document announced a public hearing to obtain input on four recently issued draft guidances relating to the regulation of human cells, tissues, or cellular or tissue-based products (HCT/Ps). The document published with conflicting information about who must register for the public hearing. This document corrects that error.
Agency Information Collection Activities: Proposed Collection; Comment Request; Current Good Manufacturing Practice for Positron Emission Tomography Drugs
Document Number: 2015-32685
Type: Notice
Date: 2015-12-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection contained in FDA's regulations on current good manufacturing practice (CGMP) for positron emission tomography (PET) drugs.
Agency Information Collection Activities: Submission for OMB Review; Comment Request; Developmental Disabilities Protection and Advocacy Statement of Goals and Priorities
Document Number: 2015-32667
Type: Notice
Date: 2015-12-29
Agency: Department of Health and Human Services
The Administration on Intellectual and Developmental Disabilities (AIDD), Administration for Community Living (ACL) is announcing an opportunity to comment on the proposed collection of 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 for public comment in response to the notice. This notice collects comments on the information collection requirements relating to an existing collection: Developmental Disabilities Protection and Advocacy Statement of Goals and Priorities (0985-0034).
National Institute on Aging; Notice of Closed Meetings
Document Number: 2015-32660
Type: Notice
Date: 2015-12-29
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2015-32659
Type: Notice
Date: 2015-12-29
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meetings
Document Number: 2015-32658
Type: Notice
Date: 2015-12-29
Agency: Department of Health and Human Services
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2015-32657
Type: Notice
Date: 2015-12-29
Agency: Department of Health and Human Services, National Institutes of Health
Neurological Devices; Reclassification of Electroconvulsive Therapy Devices Intended for Use in Treating Severe Major Depressive Episode in Patients 18 Years of Age and Older Who Are Treatment Resistant or Require a Rapid Response; Effective Date of Requirement for Premarket Approval for Electroconvulsive Therapy for Certain Specified Intended Uses
Document Number: 2015-32592
Type: Proposed Rule
Date: 2015-12-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is issuing a proposed administrative order to reclassify the electroconvulsive therapy (ECT) device for use in treating severe major depressive episode (MDE) associated with major depressive disorder (MDD) or bipolar disorder (BPD) in patients 18 years of age and older who are treatment-resistant or who require a rapid response due to the severity of their psychiatric or medical condition, which is a preamendments class III device, into class II (special controls) based on new information. FDA is also proposing to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for ECT devices for other intended uses specified in this proposed order. The Agency is also summarizing its proposed findings regarding the degree of risk of illness or injury designed to be eliminated or reduced by requiring the devices to meet the statute's approval requirements for other intended uses specified in this proposed order. In addition, FDA is announcing the opportunity for interested persons to request that the Agency change the classification of any of the devices mentioned in this document based on new information. This action implements certain statutory requirements.
Electroconvulsive Therapy Devices for Class II Intended Uses: Draft Guidance for Industry, Clinicians, and FDA Staff; Availability
Document Number: 2015-32591
Type: Notice
Date: 2015-12-29
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 ``Electroconvulsive Therapy (ECT) Devices for Class II Intended Uses: Draft Guidance for Industry, Clinicians, and FDA Staff.'' The purpose of this guidance is to make recommendations for 510(k) submissions and complying with special controls being proposed to support reclassification of ECT Devices into Class II (special controls) for severe major depressive episode (MDE) associated with Major Depressive Disorder (MDD) or Bipolar Disorder (BPD) in patients 18 years of age and older who are treatment-resistant or who require a rapid response due to the severity of their psychiatric or medical condition. This draft guidance is not final nor is it in effect at this time.
Submission for OMB Review; Comment Request
Document Number: 2015-32604
Type: Notice
Date: 2015-12-28
Agency: Department of Health and Human Services, Administration for Children and Families
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2015-32584
Type: Notice
Date: 2015-12-28
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration