December 2013 – Federal Register Recent Federal Regulation Documents

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.

The Federal Emergency Management Agency, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on a revision of a currently approved information collection. In accordance with the Paperwork Reduction Act of 1995, this notice seeks comments concerning information required by FEMA to revise National Flood Insurance Program Maps.

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.

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.

The Department of Labor (DOL) is submitting the Occupational Safety and Health Administration (OSHA) sponsored information collection request (ICR) titled, ``Student Data Form,'' to the Office of Management and Budget (OMB) for review and approval for continued use, without change, in accordance with the Paperwork Reduction Act of 1995 (PRA), 44 U.S.C. 3501 et seq.

In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 3501 et seq.), ED is proposing a new information collection.

This proposal invites comments on adding the State of Arkansas as a primary peanut-producing State under the Peanut Promotion, Research, and Information Order (Order). The Order is administered by the National Peanut Board (Board) with oversight by the U.S. Department of Agriculture (USDA). Under the Order, primary peanut-producing States must maintain a 3-year average production of at least 10,000 tons of peanuts. Arkansas's peanut production meets this requirement. Primary peanut-producing States also have a seat on the Board, and this proposal would also add a seat on the Board for the State of Arkansas. The Board recommended this action to ensure that the Board's representation reflects changes in the geographical distribution of the production of peanuts.

This rule increases the assessment rate established for the California Walnut Board (Board) for the 2013-14 and subsequent marketing years from $0.0175 to $0.0189 per kernelweight pound of merchantable walnuts. The Board locally administers the marketing order, which regulates the handling of walnuts grown in California. Assessments upon walnut handlers are used by the Board to fund reasonable and necessary expenses of the program. The marketing year begins on September 1 and ends on August 31. The assessment rate will remain in effect indefinitely unless modified, suspended, or terminated.

The Commission is noticing a recent Postal Service filing announcing its intention to change rates for Inbound Air Parcel Post (at Universal Postal Union (UPU) Rates). This notice informs the public of the filing, invites public comment, and takes other administrative steps.

This rule changes the membership of the Softwood Lumber Board (Board) established under the Softwood Lumber Research, Promotion, Consumer Education and Industry Information Order (Order). The Board administers the Order with oversight by the U.S. Department of Agriculture (USDA). Under the Order, assessments are collected from U.S. manufacturers (domestic) and importers and used for projects to promote softwood lumber within the United States. This rule revises the Board's membership to reflect the diversity of the industry in terms of size of operation; allows companies that operate in multiple geographic regions to seek representation in any region in which they operate (U.S. or import); adds flexibility for the Board to nominate eligible persons to fill vacancies that occur during a term; and re-designates the States of Virginia and West Virginia to the U.S. South Region. These changes will help facilitate program operations.

This document directs that a referendum be conducted among eligible growers of almonds in California to determine whether they favor continuance of the marketing order that regulates the handling of almonds grown in California.