April 25, 2014 – Federal Register Recent Federal Regulation Documents

The Department of Transportation (DOT), Office of the Secretary (OST), Office of Small and Disadvantaged Business Utilization (OSDBU) announces the opportunity for: (1) Business centered community- based organizations; (2) transportation-related trade associations; (3) colleges and universities; (4) community colleges or; (5) chambers of commerce, registered with the Internal Revenue Service as 501 C(6) or 501 C(3) tax-exempt organizations, to compete for participation in OSDBU's Small Business Transportation Resource Center (SBTRC) program in the West Central Region (Colorado, North Dakota, South Dakota, Nebraska, Wyoming and Utah). OSDBU will enter into Cooperative Agreements with these organizations to provide outreach to the small business community in their designated region and provide financial and technical assistance, business training programs, business assessment, management training, counseling, marketing and outreach, and the dissemination of information, to encourage and assist small businesses to become better prepared to compete for, obtain, and manage DOT funded transportation- related contracts and subcontracts at the federal, state and local levels. Throughout this notice, the term ``small business'' will refer to: 8(a), small disadvantaged businesses (SDB), disadvantaged business enterprises (DBE), women owned small businesses (WOSB), HubZone, service disabled veteran owned businesses (SDVOB), and veteran owned small businesses (VOSB). Throughout this notice, ``transportation- related'' is defined as the maintenance, rehabilitation, restructuring, improvement, or revitalization of any of the nation's modes of transportation. Funding Opportunity Number: USDOT-OST-OSDBU-SBTRC-2014-16. Catalog of Federal Domestic Assistance (CFDA) Number: 20.910 Assistance to small and disadvantaged businesses. Type of Award: Cooperative Agreement Grant. Award Ceiling: $145,000. Award Floor: $125,000. Program Authority: DOT is authorized under 49 U.S.C. 332(b)(4), (5) & (7) to design and carry out programs to assist small disadvantaged businesses in getting transportation-related contracts and subcontracts; develop support mechanisms, including management and technical services, that will enable small disadvantaged businesses to take advantage of those business opportunities; and to make arrangements to carry out the above purposes.

The Sabine-Angelina Resource Advisory Committee (RAC) will meet in Hemphill, Texas. The committee is authorized under the Secure Rural Schools and Community Self-Determination Act (Pub. L. 110-343) (the Act) and operates in compliance with the Federal Advisory Committee Act. The purpose of the committee is to improve collaborative relationships and to provide advice and recommendations to the Forest Service concerning projects and funding consistent with Title II of the Act. The meeting is open to the public. The purpose of the meeting is introduce the new Designated Federal Officer, discuss committee membership, view the ethics video, and present proposed projects.

Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Li Chen, Ph.D., Mount Sinai School of Medicine: Based on evidence and findings of an investigation report by Mount Sinai School of Medicine (MSSM) transmitted to the United States Department of Health and Human Services (HHS), Office of Research Integrity (ORI), in April 2010 and additional analysis conducted by ORI in its oversight review, ORI found that Dr. Li Chen, former Postdoctoral Fellow, Department of Gene and Cell Medicine, MSSM, engaged in research misconduct in research that was supported by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH), grant R01 DK062972 and National Institute of General Medical Sciences (NIGMS), NIH, grant P20 GM075019 and was submitted in grant applications R01 DK074695 and R01 DK083286 to NIDDK, NIH, P20 GM075019 to NIGMS, NIH, and R01 NS062054 to the National Institute of Neurological Disorders and Stroke (NINDS), NIH. ORI found that the Respondent intentionally, knowingly, and recklessly fabricated and falsified data reported in four (4) publications, one (1) submitted manuscript, and four (4) grant applications: Chen, L., & Woo, S.L.C. ``Complete and persistent phenotypic correction of phenylketonuria in mice by site-specific genome integration of murine phenylalanine hydroxylase cDNA.'' Proc. Natl. Acad. Sci. U.S.A. 102(43):15581-15586, October 2005 (hereafter referred to as ``PNAS 2005''). Chen, L., Thung, S.N., & Woo, S.L.C. ``Metabolic Basis of Sexual Dimorphism in PKU Mice After Genome-targeted PAH Gene Therapy.'' Mol. Ther. 15:1079-1085, June 2007; Retracted in December 2010 (hereafter referred to as ``Mol. Ther. June 2007''). Chen, L., & Woo, S.L.C. ``Correction in Female PKU Mice by Repeated Administration of mPAH cDNA Using phiBT1 Integration System.'' Mol. Ther. 15:1789-1795, October 2007; Retracted in December 2010 (hereafter referred to as ``Mol. Ther. Oct. 2007''). Chen, L., & Woo, S.L.C. ``Site-Specific Transgene Integration in the Human Genome Catalyzed by [Ouml]BT1 Phage Integrase.'' Hum. Gene Ther. 19:143-151, February 2008; Retracted in August 2010 (hereafter referred to as ``HGT 2008''). Chen, L., Roy, I., Prasad, P.N., & Woo, S.L.C. ``Nanoparticle-Based Gene Therapy for Metabolic Disorders: Hepatic Delivery of Minicircle DNA for Complete Correction of Phenylketonuria.'' Submitted for publication in Proc. Natl. Acad. Sci. U.S.A. (hereafter referred to as the ``PNAS 2008 manuscript''). R01 DK074695, ``Genome-targeted PAH Gene Integration in PKU Mice and Sexual Dimorphism,'' Savio L.C. Wood, Ph.D., Principal Investigator (P.I.) (hereafter referred to as ``R01 DK074695''). P20 GM075019, ``Growth, Differentiation & Genetic Alteration of Human ES Cells,'' Gordon M. Keller, Ph.D., P.I. (hereafter referred to as ``P20 GM075019''). R01 NS062054, ``Nanoparticle-medicated Gene Therapy for PKU,'' Savio L. Woo, Ph.D., P.I. (hereafter referred to as ``R01 NS062054''). R01 DK083285, ``Nanoparticle-Mediated Gene Therapy PKU,'' Savio L. Woo, Ph.D., P.I. (hereafter referred to as ``R01 DK083285''). The Respondent fabricated figures reporting the chromosomal locations of integration sites, fabricated data reporting the use of polymerase chain reaction (PCR) to determine integration frequencies, falsified data representing the detection of chromosomal translocations in human cells, and fabricated figures by falsely reporting the results of High-Performance Liquid Chromatography (HPLC) assays. The Respondent also falsified experimental data for LacZ stained liver sections and for hematoxylin and eosin (H&E) stained liver sections. Specifically, ORI finds by a preponderance of the evidence that the Respondent engaged in misconduct in science and research misconduct by intentionally, knowingly, and recklessly: 1. fabricating and/or falsifying nineteen (19) figures by falsely reporting that phenylketonuria (PKU) gene therapy experiments were successfully completed, when the available evidence shows the experiments were not performed; specifically the Respondent: (a) fabricated figures where DNA sequencing was purportedly used to identify the chromosomal locations of integration sites for the PAH gene in mouse and human cells, reported in seven (7) figures: PNAS 2005, Figure 2A HGT 2008, Figures 3b and 3c R01 NS062054, Figures 3 and 20 R01 DK074695, Figure 6 R01 DK083286, Figure 17 P20 GM075019, Figure 4 (b) fabricated data purportedly representing the use of PCR to determine integration frequencies for the phenylalanine hydroxylase (PAH) gene and the secreted embryonic alkaline phosphatase (SEAP) reporter gene, in mouse and human cells, reported in eleven (11) figures: PNAS 2005, Figures 2C and 3B Mol. Ther. June 2007, Figures 2a and 5a Mol. Ther. Oct. 2007, Figures 2d and 5a HGT 2008, Figure 4 R01 NS062054, Figures 4b and 10a R01 DK074695, Figure 7b R01 DK083286, Figure 2b (c) falsified figures representing the detection of chromosomal tranlocations in human cells, purportedly determined by PCR in two (2) figures: HGT 2008, Figure 5a R01 NS062054, Figure 21a 2. fabricating the results of HPLC assays to show generally lowered blood levels of phenylalanine after PKU gene therapy and to show liver levels of BH4 when the Respondent did not have the HPLC data needed to support those claims; specifically the Respondent: (a) fabricated serum phenylalanine graphs in: PNAS 2005, Figure 4B; this false data also is presented in R01 DK074695, Figure 10b Mol. Ther. June 2007, Figure 1a; this false data also is presented in R01 DK074695, Figure 11 R01 DK083286, Figure 3; this false data also is presented in Mol. Ther. June 2007, Figure 3, and R01 NS062054, Figure 7 Mol. Ther. Oct. 2007, Figure 4a; this false data also is presented in R01 NS062054, Figure 9a PNAS 2008 manuscript, Figure 4 (b) fabricated graphs for BH4 levels in: Mol. Ther. June 2007, Figure 5c; this false data also is presented in R01 NS062054, Figure 8c 3. falsely reporting the results of LacZ stained liver sections by reusing and relabeling an image and claiming that it represents different experiments; specifically, the same image was used to represent mice treated with a nanoplex gene delivery system in R01 NS062054, Figure 14b (right panel), and also to represent a wholly different experiment for mice treated with 10 injections of the phiBT1 integrase system alone in R01 NS062054, Figure 4c (right panel), and Mol. Ther. Oct. 2007, Figure 2b (D panel) 4. falsely reporting the results of H&E stained liver sections in R01 NS062054, Figure 6, by using the identical image to represent four (4) different experimental treatments of H&E stained liver sections; specifically the Respondent reused and relabeled one image to represent liver sections from mice that received either 1 or 10 injections, with or without the phiBT1 integrase plasmid. The Respondent failed to take responsibility for the fabrication and falsification described in ORI's findings. The following administrative actions have been implemented for a period of three (3) years, beginning on April 11, 2014: (1) Respondent is debarred from any contracting or subcontracting with any agency of the United States Government and from eligibility for, 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 Office of Management and Budget (OMB) Guidelines to Agencies on Governmentwide Debarment and Suspension, 2 CFR part 180 (collectively the ``Debarment Regulations''); and (2) Respondent is prohibited from serving in any advisory capacity to PHS, including but not limited to service on any PHS advisory committee, board, and/or peer review committee, or as a consultant.

NMFS is prohibiting directed fishing for Greenland turbot in the Aleutian Islands subarea of the Bering Sea and Aleutian Islands management area (BSAI). This action is necessary to prevent exceeding the 2014 Greenland turbot initial total allowable catch (ITAC) in the Aleutian Islands subarea of the BSAI.

The Pacific Fishery Management Council's (Pacific Council) ad hoc Lower Columbia River Natural Coho Workgroup (LRC Workgroup) will hold a public work session in Portland, OR. The meeting is open to the public, but is not intended as a public hearing. Public comments will be taken at the discretion of the LRC Workgroup chair as time allows.

The Health Resources and Services Administration (HRSA) is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by Section 2112(b)(2) of the Public Health Service (PHS) Act, as amended. While the Secretary of Health and Human Services is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.

Under the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3501 et seq.), and as part of its continuing effort to reduce paperwork and respondent burden, the National Science Foundation (NSF) is inviting the general public and other Federal agencies to comment on this proposed continuing information collection. This is the second notice for public comment; the first was published in the Federal Register at 78 FR 68479, November 14, 2013, and no substantial comments were received. NSF is forwarding the proposed submission to the Office of Management and Budget (OMB) for clearance simultaneously with the publication of this second notice. This collection adds five new questions to the Medical History section of the forms. Three questions are related to Tuberculosis and were added to give medical examiners better information on which to base further testing, including whether to expose participants to additional doses of radiation. Two questions are related to diving. They were added to inform the medical examiners and healthcare providers of any pre- existing medical issues for those engaging in scientific diving in the Polar Regions. The full submission may be found at https:// www.reginfo.gov/public/do/PRAMain.

The Office of the Secretary of Defense is deleting a system of records notice in its existing inventory of record systems subject to the Privacy Act of 1974, as amended. The notice is DGC 05, Administrative Files on Active Psychiatric Consultants to Department of Defense (August 27, 1993, 58 FR 45320).

The Department of Defense (DoD) is publishing this notice to announce that it is amending the charter for the Response Systems to Adult Sexual Assault Crimes Panel (``the Panel'').

The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by Novus International, Inc., proposing that the food additive regulations be amended to provide for the safe use of ethoxyquin in rendered fats and oils used in animal feed.

The Committee is proposing to add products and services to the Procurement List that will be furnished by nonprofit agencies employing persons who are blind or have other severe disabilities, and deletes a product previously furnished by such agency. Comments Must Be Received on or Before: 5/26/2014.

NMFS implements an accountability measure (AM) for recreational gray triggerfish in the Gulf of Mexico (Gulf) reef fish fishery for the 2014 fishing year through this temporary final rule. Based on the 2013 recreational annual catch limit (ACL) overage, NMFS reduces the 2014 recreational annual catch target (ACT) and ACL for gray triggerfish to 0 lb (0 kg) through this temporary rule. Therefore, NMFS closes the recreational sector for gray triggerfish in the Gulf EEZ at 12:01 a.m., local time, May 1, 2014, until January 1, 2015. This action is necessary to reduce overfishing of the Gulf gray triggerfish resource.

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

The Reagan-Udall Foundation for the Food and Drug Administration (FDA), published a document in the Federal Register of April 3, 2014, concerning the Foundation's Annual Open Public Meeting on May 14, 2014. The document contained the incorrect address for the meeting location.

This is a notice of an Administrative declaration of a disaster for the State of Mississippi dated 04/14/2014. Incident: Severe Weather and Flooding. Incident Period: 03/28/2014 through 03/29/2014.

The Coast Guard announces the availability of Revision 7 to Maritime Security (MARSEC) Directive 104-6, which provides guidelines for U.S. vessels operating in high risk waters (HRW) where acts of terrorism, piracy, and armed robbery against ships are prevalent, as well as specific guidance for offshore supply vessels and liftboats operating in the Gulf of Guinea. The directive contains security- sensitive information and therefore cannot be made available to the general public. U.S. vessel owners and operators who have needed to take action under previous versions of MARSEC Directive 104-6, or whose vessels operate in waters off the coast of Africa, should immediately contact their local Coast Guard Captain of the Port or District Commander for a copy of Revision 7, which contains important updates to the locations of HRW and to the guidelines for addressing security risks in those waters. The Coast Guard advises such owners and operators that, under Revision 7, they may need to take specific actions in accordance with MARSEC Directive 104-6 before their vessel enters HRW. This notice is issued under the authority of 5 U.S.C. 552(a).

The Coast Guard proposes to establish regulations for annual, combined marine events that require the establishment of a temporary safety zone within the Captain of the Port Zone Buffalo on the Cuyahoga River, Cleveland, OH. This proposed safety zone regulation is necessary to protect the surrounding public, spectators, participants, and vessels from the hazards associated with the rowing regatta in the narrow waterway of the Cuyahoga River. This proposed rule is intended to restrict vessels annually from a portion of the Cuyahoga River for up to 10 hours during the combined Dragon Boat Festival and the Head of the Cuyahoga Regatta.

The Coast Guard proposes to establish a temporary safety zone on the navigable waters of Byram Harbor near Greenwich, CT for the Belle Haven Club fireworks display. This action is necessary to provide for the safety of life on navigable waters during the event. The safety zone will facilitate public notification of the event and provide protective measures for the maritime public and event participants from the hazards associated with this event. Entering into, transiting through, remaining, anchoring or mooring within this regulated area would be prohibited unless authorized by the Captain of the Port (COTP) Sector Long Island Sound.

The Department of Defense is publishing this notice to announce that it is reestablishing the charter for the Board of Advisors to the Presidents of the Naval Postgraduate School and the Naval War College (``the Board'').