Department of Health and Human Services December 23, 2013 – Federal Register Recent Federal Regulation Documents

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
National Institute of Biomedical Imaging and Bioengineering; Notice of Closed Meeting
Document Number: 2013-30403
Type: Notice
Date: 2013-12-23
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: 2013-30402
Type: Notice
Date: 2013-12-23
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: 2013-30401
Type: Notice
Date: 2013-12-23
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: 2013-30400
Type: Notice
Date: 2013-12-23
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Neurological Disorders and Stroke
Document Number: 2013-30399
Type: Notice
Date: 2013-12-23
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Closed Meeting
Document Number: 2013-30398
Type: Notice
Date: 2013-12-23
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Meeting
Document Number: 2013-30397
Type: Notice
Date: 2013-12-23
Agency: Department of Health and Human Services, National Institutes of Health
Clinical Center; Notice of Meeting
Document Number: 2013-30396
Type: Notice
Date: 2013-12-23
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2013-30395
Type: Notice
Date: 2013-12-23
Agency: Department of Health and Human Services, National Institutes of Health
National Library of Medicine; Notice of Closed Meeting
Document Number: 2013-30393
Type: Notice
Date: 2013-12-23
Agency: Department of Health and Human Services, National Institutes of Health
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: 2013-30365
Type: Notice
Date: 2013-12-23
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services