Department of Health and Human Services 2013 – Federal Register Recent Federal Regulation Documents

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Medicare and Medicaid Programs; Emergency Preparedness Requirements for Medicare and Medicaid Participating Providers and Suppliers
Document Number: 2013-30724
Type: Proposed Rule
Date: 2013-12-27
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This proposed rule would establish national emergency preparedness requirements for Medicare- and Medicaid-participating providers and suppliers to ensure that they adequately plan for both natural and man-made disasters, and coordinate with federal, state, tribal, regional, and local emergency preparedness systems. It would also ensure that these providers and suppliers are adequately prepared to meet the needs of patients, residents, clients, and participants during disasters and emergency situations. We are proposing emergency preparedness requirements that 17 provider and supplier types must meet to participate in the Medicare and Medicaid programs. Since existing Medicare and Medicaid requirements vary across the types of providers and suppliers, we are also proposing variations in these requirements. These variations are based on existing statutory and regulatory policies and differing needs of each provider or supplier type and the individuals to whom they provide health care services. Despite these variations, our proposed regulations would provide generally consistent emergency preparedness requirements, enhance patient safety during emergencies for persons served by Medicare- and Medicaid-participating facilities, and establish a more coordinated and defined response to natural and man- made disasters.
Medicare Program; Right of Appeal for Medicare Secondary Payer Determination Relating to Liability Insurance (Including Self-Insurance), No Fault Insurance, and Workers' Compensation Laws and Plans
Document Number: 2013-30661
Type: Proposed Rule
Date: 2013-12-27
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This proposed rule would implement provisions of the Strengthening Medicare and Repaying Taxpayers Act of 2012 (SMART Act) which require us to provide a right of appeal and an appeal process for liability insurance (including self-insurance), no-fault insurance, and workers' compensation laws or plans when Medicare pursues a Medicare Secondary Payer (MSP) recovery claim directly from the liability insurance (including self-insurance), no fault insurance, or workers' compensation law or plan.
Solicitation of New Safe Harbors and Special Fraud Alerts
Document Number: 2013-30429
Type: Proposed Rule
Date: 2013-12-27
Agency: Department of Health and Human Services, Office of Inspector General
In accordance with section 205 of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), this annual notice solicits proposals and recommendations for developing new and modifying existing safe harbor provisions under the Federal anti-kickback statute (section 1128B(b) of the Social Security Act), as well as developing new OIG Special Fraud Alerts.
Draft Generic Drug User Fee Act Information Technology Plan; Availability for Comment
Document Number: 2013-31008
Type: Notice
Date: 2013-12-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability for public comment of the draft information technology (IT) plan entitled ``GDUFA Information Technology Plan.'' This plan is intended to provide FDA's approach for enhancing business processes, data quality and consistency, supporting technologies, and IT operations as described in the Generic Drug User Fee Act (GDUFA) Performance Goals and Procedures for Fiscal Years 2013 through 2017. FDA is publishing a draft version of the IT plan for comment to allow industry and other interested stakeholders to provide feedback as FDA moves towards a fully automated standards-based environment that enhances the regulatory review process for human pharmaceuticals.
National Institute for Occupational Safety and Health Personal; Notice of public meeting in Endicott, New York
Document Number: 2013-30905
Type: Notice
Date: 2013-12-26
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces a public meeting to present results from a study of former workers of the International Business Machine (IBM) facility in Endicott, New York. This meeting is being held to present study results to stakeholders and members of the public and to offer the opportunity for comments. Meeting Time and Date: January 23, 2014, 6:30 p.m.-8:30 p.m. EST, or after the last public commenter has spoken, whichever occurs first.
Notice of Meeting
Document Number: 2013-30901
Type: Notice
Date: 2013-12-26
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
In accordance with section 10 (a)(2) of the Federal Advisory Committee Act (5 U.S.C. App. 2), announcement is made of an Agency for Healthcare Research and Quality (AHRQ) Special Emphasis Panel (SEP) meeting on ``AHRQ RFA-HS14-003, Disseminating Patient Centered Outcomes Research to Improve Healthcare Delivery Systems (R18)''. Each SEP meeting will commence in open session before closing to the public for the duration of the meeting.
Notice of Request for Comments on Chapters 6 and 8 of the NIOSH document titled: “Criteria for a Recommended Standard: Occupational Exposure to Diacetyl and 2,3-pentanedione”
Document Number: 2013-30900
Type: Notice
Date: 2013-12-26
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) is inviting comments on Chapter 6 and a new section of Chapter 8 of the draft document, ``Criteria for a Recommended Standard: Occupational Exposure to Diacetyl and 2,3-pentanedione.'' To view the notice and related materials, visit http://www.regulations.gov and enter CDC-2013- 0021 in the search field and click ``Search.'' Public Comment Period: Comments must be received by February 10, 2014. Status: Comments are being sought from individuals including scientists and representatives from various government agencies, industry, labor, and other stakeholders, and also the public.
Notice of Meeting
Document Number: 2013-30899
Type: Notice
Date: 2013-12-26
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
In accordance with section 10 (a)(2) of the Federal Advisory Committee Act (5 U.S.C. App. 2), announcement is made of an Agency for Healthcare Research and Quality (AHRQ) Special Emphasis Panel (SEP) meeting on ``AHRQ RFA-HS14-004, PCOR AHRQ Training Program on Patient- Centered Outcomes Methods & Standard Research (R25)''. Each SEP meeting will commence in open session before closing to the public for the duration of the meeting.
Notice of Meetings
Document Number: 2013-30888
Type: Notice
Date: 2013-12-26
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
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. section 552b(c)(4), and 5 U.S.C. section 552b(c)(6).
Agency Information Collection Activities; Proposed Collection; Public Comment Request
Document Number: 2013-30840
Type: Notice
Date: 2013-12-26
Agency: Department of Health and Human Services, Office of the Secretary
In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). The ICR is for extending the use of the approved information collection assigned OMB control number 0955-0009, which expires on February 28, 2014. Prior to submitting that ICR to OMB, OS seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Agency Information Collection Activities; Submission to OMB for Review and Approval; Public Comment Request
Document Number: 2013-30839
Type: Notice
Date: 2013-12-26
Agency: Department of Health and Human Services, Office of the Secretary
In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, has submitted an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB) for review and approval. The ICR is for a new collection. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public on this ICR during the review and approval period.
Draft Prescription Drug User Fee Act V Information Technology Plan; Availability for Comment
Document Number: 2013-30818
Type: Notice
Date: 2013-12-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability for public comment of the draft information technology (IT) plan entitled ``PDUFA V Information Technology Plan.'' This plan is intended to provide FDA's approach for enhancing business processes, data quality and consistency, supporting technologies, and IT operations as described in the Prescription Drug User Fee Act (PDUFA) Reauthorization Performance Goals and Procedures for Fiscal Years 2013 through 2017. FDA is publishing a draft version of the IT plan for comment to allow industry and other interested stakeholders to provide feedback as FDA moves towards a fully automated standards-based environment that enhances the regulatory review process for human pharmaceuticals.
Submission for OMB Review; 30-Day Comment Request: Early Career Reviewer Program Online Application System-Center for Scientific Review (CSR)
Document Number: 2013-30817
Type: Notice
Date: 2013-12-26
Agency: Department of Health and Human Services, National Institutes of Health
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Center for Scientific Review, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on March 13, 2013, page 15959 and allowed 60days 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 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 Proposed Collection: Early Career Reviewer Program Online Application SystemExisting collection in use without an OMB number Center for Scientific Review (CSR), National Institutes of Health (NIH). Need and Use of Information Collection: The Center for Scientific Review (CSR) is the portal for NIH grant applications and their review for scientific merit. Our mission is to see that NIH grant applications receive fair, independent, expert, and timely reviewsfree from inappropriate influencesso NIH can fund the most promising research. To accomplish this goal, Scientific Review Officers (SRO) form study sections consisting of scientists who have the technical and scientific expertise to evaluate the merit of grant applications. The CSR Early Career Reviewer (ECR) program was developed to identify and train qualified scientists who are early in their scientific careers and who have not had prior CSR review experience. Currently, the application process involves repeated email interactions with potential applicants and manual management of information. To make the application process more efficient for applicants and for CSR staff, we have collaborated with the Information Management Branch at CSR to develop online application software which includes the collection of applicants' names, contact information, and professional CVs. This PRA clearance request is to deploy the online application software for ECR program applicantsthe Early Career Reviewer Application and Vetting System (EAVS). OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 650.
Proposed Information Collection Activity; Comment Request
Document Number: 2013-30809
Type: Notice
Date: 2013-12-26
Agency: Department of Health and Human Services, Administration for Children and Families
Agency Information Collection Activities; Proposed Collection; Comment Request; Information From United States Firms and Processors That Export to the European Community
Document Number: 2013-30804
Type: Notice
Date: 2013-12-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) 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 reporting requirements in implementing the lists of United States (U.S.) firms/processors exporting shell eggs, dairy products, game meat, game meat products, animal casings, gelatin, and collagen to the European Community (the EC).
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2013-30801
Type: Notice
Date: 2013-12-26
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Draft Guidance for Industry on Naming of Drug Products Containing Salt Drug Substances; Availability
Document Number: 2013-30800
Type: Notice
Date: 2013-12-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Naming of Drug Products Containing Salt Drug Substances.'' The United States Pharmacopeial (U.S.P.) Convention has adopted a monograph naming policy that changed the nomenclature for compendial drug products that contain a salt. Under the new policy, drug names and strengths for new compendial drug products will be based on the active moiety. The name and strength of the active ingredient (e.g., salt) will appear elsewhere on the drug product label and labeling. The policy became official on May 1, 2013. This draft guidance describes the U.S.P. policy, discusses the Center for Drug Evaluation and Research's (CDER's) application of the policy, and recommends how CDER and industry can implement the policy.
Allergenic Products Advisory Committee; Notice of Meeting
Document Number: 2013-30799
Type: Notice
Date: 2013-12-26
Agency: Food and Drug Administration, Department of Health and Human Services
Center For Scientific Review; Notice of Closed Meetings
Document Number: 2013-30747
Type: Notice
Date: 2013-12-26
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases Notice of Closed Meeting
Document Number: 2013-30746
Type: Notice
Date: 2013-12-26
Agency: Department of Health and Human Services, National Institutes of Health
Government-Owned Inventions; Availability for Licensing
Document Number: 2013-30745
Type: Notice
Date: 2013-12-26
Agency: Department of Health and Human Services, National Institutes of Health
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing 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.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2013-30706
Type: Notice
Date: 2013-12-26
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: 2013-30671
Type: Notice
Date: 2013-12-26
Agency: Agency for Toxic Substances and Disease Registry, Department of Health and Human Services
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2013-30646
Type: Notice
Date: 2013-12-24
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Agency Information Collection Activities; Proposed Collection; Comment Request; Food and Drug Administration Rapid Response Surveys (Generic Clearance)
Document Number: 2013-30630
Type: Notice
Date: 2013-12-24
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 use of rapid response surveys to obtain data on safety information to support quick turnaround decisionmaking about potential safety problems or risk management solutions from health care professionals, hospitals, and other user facilities (e.g., nursing homes, etc.); consumers; manufacturers of biologics, drugs, and medical devices; distributors; and importers, when FDA must quickly determine whether or not a problem with a biologic, drug, or medical device impacts the public health.
Agency Information Collection Activities: Proposed Collection: Public Comment Request
Document Number: 2013-30613
Type: Notice
Date: 2013-12-24
Agency: Department of Health and Human Services, Health Resources and Services Administration, Administration for Children and Families
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) and the Administration for Children and Families (ACF) announce 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 and ACF seek comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
National Institute of Mental Health Notice of Meeting
Document Number: 2013-30599
Type: Notice
Date: 2013-12-24
Agency: Department of Health and Human Services, National Institutes of Health
Designation of a Class of Employees for Addition to the Special Exposure Cohort
Document Number: 2013-30584
Type: Notice
Date: 2013-12-24
Agency: Department of Health and Human Services
HHS gives notice of a decision to designate a class of employees from the Rocky Flats Plant in Golden, Colorado, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On December 7, 2013, the Secretary of HHS designated the following class of employees as an addition to the SEC:
Designation of a Class of Employees for Addition to the Special Exposure Cohort
Document Number: 2013-30581
Type: Notice
Date: 2013-12-24
Agency: Department of Health and Human Services
HHS gives notice of a decision to designate a class of employees from the Sandia National Laboratories-Livermore in Livermore, California, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On December 7, 2013, the Secretary of HHS designated the following class of employees as an addition to the SEC:
Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
Document Number: 2013-30580
Type: Notice
Date: 2013-12-24
Agency: Food and Drug Administration, Department of Health and Human Services
Ophthalmic Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
Document Number: 2013-30579
Type: Notice
Date: 2013-12-24
Agency: Food and Drug Administration, Department of Health and Human Services
Science Advisory Board to the National Center for Toxicological Research; Notice of Meeting
Document Number: 2013-30578
Type: Notice
Date: 2013-12-24
Agency: Food and Drug Administration, Department of Health and Human Services
Amendments to Excepted Benefits
Document Number: 2013-30553
Type: Proposed Rule
Date: 2013-12-24
Agency: Employee Benefits Security Administration, Department of Labor, Department of Health and Human Services, Internal Revenue Service, Department of Treasury, Department of the Treasury
This document contains proposed rules that would amend the regulations regarding excepted benefits under the Employee Retirement Income Security Act of 1974, the Internal Revenue Code, and the Public Health Service Act. Excepted benefits are generally exempt from the health reform requirements that were added to those laws by the Health Insurance Portability and Accountability Act and the Patient Protection and Affordable Care Act.
Appendix 4 to Draft Qualitative Risk Assessment of Risk of Activity/Food Combinations for Activities (Outside the Farm Definition) Conducted in a Facility Co-Located on a Farm; Availability
Document Number: 2013-30375
Type: Proposed Rule
Date: 2013-12-24
Agency: Food and Drug Administration, Department of Health and Human Services
On January 16, 2013, the Food and Drug Administration (FDA) announced the availability of, and requested comment on, a document entitled ``Draft Qualitative Risk Assessment of Risk of Activity/Food Combinations for Activities (Outside the Farm Definition) Conducted in a Facility Co-Located on a Farm'' (the draft RA). FDA is now announcing the availability of, and requesting comment on, a document entitled ``Appendix 4 to Draft Qualitative Risk Assessment of Risk of Activity/ Food Combinations for Activities (Outside the Farm Definition) Conducted in a Facility Co-Located on a Farm'' (the draft RA Appendix). The purpose of the draft RA Appendix is to provide a science-based risk analysis of those foods whose production would be considered low risk with respect to the risk of intentional adulteration caused by acts of terrorism. The appendix supplements the science-based risk analysis already included in the draft RA, which does not consider the risk of intentional adulteration caused by acts of terrorism. FDA conducted this evaluation to satisfy requirements of the FDA Food Safety Modernization Act (FSMA) to conduct a science-based risk analysis and to consider the results of that analysis in rulemaking that is required by FSMA.
Focused Mitigation Strategies To Protect Food Against Intentional Adulteration
Document Number: 2013-30373
Type: Proposed Rule
Date: 2013-12-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is proposing to require domestic and foreign food facilities that are required to register under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to address hazards that may be intentionally introduced by acts of terrorism. These food facilities would be required to identify and implement focused mitigation strategies to significantly minimize or prevent significant vulnerabilities identified at actionable process steps in a food operation. FDA is proposing these requirements as part of our implementation of the FDA Food Safety Modernization Act (FSMA). Further, as part of the proposal, FDA discusses an approach to addressing economically motivated intentional adulteration. We expect the proposed rule, if finalized as proposed, would help to protect food from intentional adulteration caused by acts of terrorism.
Focused Mitigation Strategies To Protect Food Against Intentional Adulteration; Public Meeting on Proposed Rule
Document Number: 2013-30372
Type: Proposed Rule
Date: 2013-12-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing a public meeting to discuss the proposed rule to require domestic and foreign food facilities that are required to register under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to address hazards that may be intentionally introduced by acts of terrorism. FDA is proposing these requirements as part of our implementation of the FDA Food Safety Modernization Act (FSMA). The purpose of the public meeting is to inform the public of the provisions of the proposed rule and the rulemaking process (including how to submit comments, data, and other information to the rulemaking docket) as well as solicit oral stakeholder and public comments on the proposed rule and to respond to questions about the rule.
Health Insurance Exchanges; Approval of an Application by the Accreditation Association for Ambulatory Health Care (AAAHC) To Be a Recognized Accrediting Entity for the Accreditation of Qualified Health Plans
Document Number: 2013-30522
Type: Notice
Date: 2013-12-23
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final notice announces our decision to approve the Accreditation Association for Ambulatory Health Care (AAAHC) for recognition as an accrediting entity for the purposes of fulfilling the accreditation requirement as part of qualified health plan (QHP) certification.
Agency Information Collection Activities; Submission to OMB for Review and Approval; Public Comment Request
Document Number: 2013-30500
Type: Notice
Date: 2013-12-23
Agency: Department of Health and Human Services, Office of the Secretary
In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, has submitted an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB) for review and approval. The ICR is for a new collection. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public on this ICR during the review and approval period.
Agency Information Collection Activities; Proposed Collection; Public Comment Request
Document Number: 2013-30467
Type: Notice
Date: 2013-12-23
Agency: Department of Health and Human Services, Office of the Secretary
In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). The ICR is for extending the use of the approved information collection assigned OMB control number 0945-0006, which expires on March 31, 2014. Prior to submitting that ICR to OMB, OS seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
DSM Nutritional Products; Filing of Food Additive Petition (Animal Use)
Document Number: 2013-30462
Type: Proposed Rule
Date: 2013-12-23
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that DSM Nutritional Products has filed a petition proposing that the food additive regulations be amended to provide for the safe use of ethoxyquin in vitamin D formulations, including 25-hydroxyvitamin D3, used in animal food.
DSM Nutritional Products; Filing of Food Additive Petition (Animal Use)
Document Number: 2013-30461
Type: Proposed Rule
Date: 2013-12-23
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that DSM Nutritional Products has filed a petition proposing that the food additive regulations be amended to provide for the safe use of 25- hydroxyvitamin D3 in feed for laying and breeding hens.
Basic Health Program: Proposed Federal Funding Methodology for Program Year 2015
Document Number: 2013-30435
Type: Proposed Rule
Date: 2013-12-23
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This document provides the methodology and data sources necessary to determine federal payment amounts made to states that elect to establish a Basic Health Program certified by the Secretary under section 1331 of the Patient Protection and Affordable Care Act (the Affordable Care Act) to offer health benefits coverage to low- income individuals otherwise eligible to purchase coverage through Affordable Insurance Exchanges.
Emergency Clearance: Public Information Collection Requirements Submitted to the Office of Management and Budget (OMB)
Document Number: 2013-30434
Type: Notice
Date: 2013-12-23
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Prospective Grant of Exclusive License for: Convection Enhanced Delivery of a Therapeutic Agent With a Surrogate Tracer for Treating Cancer and Urological Diseases
Document Number: 2013-30430
Type: Notice
Date: 2013-12-23
Agency: Department of Health and Human Services, National Institutes of Health
This is notice, in accordance with 35 U.S.C. 209 and 37 CFR 404.7, that the National Institutes of Health (NIH), Department of Health and Human Services, is contemplating the grant of an exclusive worldwide license to practice the inventions embodied in: HHS Ref. No E-202-2002/0 ``Method for Convection Enhanced Delivery of Therapeutic Agents'', U.S. Provisional Patent Application 60/413,673 (filed September 24, 2002; expired), International Patent Application No. PCT/ US2003/30155 (filed September 24, 2003; nationalized), U.S. Patent Application 7,371,225, European Patent Application 03756863.1, Australian Patent 2003299140, to Medicenna Therapeutics, Inc. having a principle place of business in 1075 West Georgia St., Vancouver, BC, Canada V6E 3C9. The United States of America is an assignee to the patent rights of these inventions. The contemplated exclusive license may be in a field of use directed to the treatment of cancers and urological disorders that express IL-4 receptor on their cell surface by administering cpIL4- PE38KDEL by convection enhanced deliver along with a Gd-DTPA surrogate tracer.
Findings of Research Misconduct
Document Number: 2013-30424
Type: Notice
Date: 2013-12-23
Agency: Department of Health and Human Services, Office of the Secretary
Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Dong-Pyou Han, Ph.D., Iowa State University of Science and Technology: Based on the report of an inquiry conducted by the Iowa State University of Science and Technology (ISU), a detailed admission by the Respondent, and additional analysis conducted by ORI, ORI and ISU found that Dr. Dong-Pyou Han, former Research Assistant Professor, Department of Biomedical Services, ISU, engaged in research misconduct in research supported by National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), grants P01 AI074286, R33 AI076083, and U19 AI091031. ORI and ISU found that the Respondent falsified results in research to develop a vaccine against human immunodeficiency virus-1 (HIV-1) by intentionally spiking samples of rabbit sera with antibodies to provide the desired results. The falsification made it appear that rabbits immunized with the gp41-54 moiety of the HIV gp41 glycoprotein induced antibodies capable of neutralizing a broad range of HIV-1 strains, when the original sera were weakly or non-reactive in neutralization assays. Falsified neutralization assay results were widely reported in laboratory meetings, seven (7) national and international symposia between 2010 and 2012, and in grant applications and progress reports P01 AI074286-03, -04, -05, and -06; R33 AI076083-04; U19 AI091031-01 and -03; and R01 AI090921-01. Specifically: a. Respondent falsified research materials when he provided collaborators with sera for neutralization assays from (i) rabbits immunized with peptides from HIV gp41-54Q (and related antigens HR1- 54Q, gp41-54Q-OG, gp41-54Q-GHC, gp41-54Q-Cys and Cys-gp41-54Q) to assay HIV neutralizing activity, when Respondent had spiked the samples with human IgG known to contain broadly neutralizing antibodies to HIV-1; and (ii) rabbits immunized with HIV gp41-54Q to assay HIV neutralizing activity, when Respondent had spiked the samples with sera from rabbits immunized with HIV-1 gp120 that neutralized HIV. b. Respondent falsified data files for neutralization assays, and provided false data to his laboratory colleagues, to make it appear that rabbits immunized with gp41-54Q and recombinant Lactobacillus expressing gp41- 64 (LAB gp41-64) produced broadly reactive neutralizing antibodies, by changing the numbers to show that samples with little or no neutralizing activity had high activity. Dr. Han has entered into a Voluntary Exclusion Agreement and has voluntarily agreed for a period of three (3) years, beginning on November 25, 2013: (1) To exclude himself from any contracting or subcontracting with any agency of the United States Government and from eligibility or involvement in nonprocurement programs of the United States Government referred to as ``covered transactions'' pursuant to HHS' Implementation (2 CFR Part 376 et seq) of OMB Guidelines to Agencies on Governmentwide Debarment and Suspension, 2 CFR Part 180 (collectively the ``Debarment Regulations''); and (2) to exclude himself voluntarily from serving in any advisory capacity to the U.S. Public Health Service (PHS) including, but not limited to, service on any PHS advisory committee, board, and/or peer review committee, or as a consultant.
Center For Scientific Review; Notice of Closed Meetings
Document Number: 2013-30408
Type: Notice
Date: 2013-12-23
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Neurological Disorders and Stroke; Notice of Closed Meeting
Document Number: 2013-30407
Type: Notice
Date: 2013-12-23
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Notice of Meeting
Document Number: 2013-30406
Type: Notice
Date: 2013-12-23
Agency: Department of Health and Human Services, National Institutes of Health
National Human Genome Research Institute; Notice of Closed Meeting
Document Number: 2013-30405
Type: Notice
Date: 2013-12-23
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2013-30404
Type: Notice
Date: 2013-12-23
Agency: Department of Health and Human Services, National Institutes of Health