February 5, 2013 – Federal Register Recent Federal Regulation Documents

Reader Aids
Document Number: FR-2013-02-05-ReaderAids
Type: Reader Aids
Date: 2013-02-05
Steel Wire Garment Hangers From the Socialist Republic of Vietnam: Antidumping Duty Order
Document Number: 2013-02637
Type: Notice
Date: 2013-02-05
Agency: Department of Commerce, International Trade Administration
Based on affirmative final determinations by the Department of Commerce (``the Department'') and the International Trade Commission (``ITC''), the Department is issuing an antidumping duty order on steel wire garment hangers from the Socialist Republic of Vietnam (``Vietnam'').
Certain Steel Wire Garment Hangers From the Socialist Republic of Vietnam: Countervailing Duty Order
Document Number: 2013-02635
Type: Notice
Date: 2013-02-05
Agency: Department of Commerce, International Trade Administration
Based on affirmative final determinations by the Department of Commerce (the Department) and the U.S. International Trade Commission (ITC), the Department is issuing a countervailing duty order on certain steel wire garment hangers from the Socialist Republic of Vietnam (Vietnam).
Sunshine Act Meetings
Document Number: 2013-02619
Type: Notice
Date: 2013-02-05
Agency: Nuclear Regulatory Commission, Agencies and Commissions
Sunshine Act Meeting; Finance, Budget & Program Committee Meeting of the Board of Directors
Document Number: 2013-02604
Type: Notice
Date: 2013-02-05
Agency: Neighborhood Reinvestment Corporation, Agencies and Commissions
Sunshine Act Meeting; Audit Committee Meeting of the Board of Directors
Document Number: 2013-02602
Type: Notice
Date: 2013-02-05
Agency: Neighborhood Reinvestment Corporation, Agencies and Commissions
First Phase of the Forest Planning Process for the Bio-Region; Correction
Document Number: 2013-02588
Type: Notice
Date: 2013-02-05
Agency: Department of Agriculture, Forest Service
The Department of Agriculture (USDA), Forest Service, Pacific Southwest Region, published a notice in the Federal Register of January 24, 2013, (78 FR 5165) which concerned initiating a forest planning process under the new planning rule entitled First Phase of the Forest Planning Process for the Bio-Region. The document contained incorrect wording describing the Notice as a Notice of Intent and introducing terms associated with National Environmental Policy Act (NEPA) process, and extraneous material not associated with the forest planning revision process.
Request for Comment: Input on Recommendations from the Council of Councils Working Group on Use of Chimpanzees in NIH-Supported Research
Document Number: 2013-02507
Type: Notice
Date: 2013-02-05
Agency: Department of Health and Human Services, National Institutes of Health
The National Institutes of Health (NIH) Council of Councils received and adopted the recommendations and Report of the NIH Council of Councils Working Group on the Use of Chimpanzees in NIH-Supported Research on January 22, 2013. The report is posted on the NIH Web site at https://dpcpsi.nih.gov/council/working_group_message.aspx. The agency will consider the recommendations contained in the report as the agency formulates policy. The NIH also announces the opening of a Request for Comment (RFC) period to collect input on the recommendations from interested parties. Comments will be accepted until Saturday, March 23, 2013, via the comment database at https:// grants.nih.gov/grants/rfi/rfi.cfm?ID=31. In the interim, NIH will continue to apply its policy on Research Involving Chimpanzees (see NOT-OD-12-025; https://grants.nih.gov/grants/guide/notice-files/NOT-OD- 12-025.html.)
Proposed Collection; Comment Request: Women's Health Initiative Observational Study
Document Number: 2013-02505
Type: Notice
Date: 2013-02-05
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 be submitted to the Office of Management and Budget (OMB) for review and approval. Proposed Collection: Title: The Women's Health Initiative (WHI) Observational Study. Type of Information Collection Request: Revision OMB 0925-0414. Need and Use of Information Collection: This study will be used by the NIH to evaluate risk factors for chronic disease among older women by developing and following a large cohort of postmenopausal women and relating subsequent disease development to baseline assessments of historical, physical, psychosocial, and physiologic characteristics. In addition, the observational study will complement the clinical trial (which has received clinical exemption) and provide additional information on the common causes of frailty, disability and death for postmenopausal women, namely, coronary heart disease, breast and colorectal cancer, and osteoporotic fractures. Continuation of follow-up for ascertainment of medical history update forms will provide essential data for outcomes assessment for this population of aging women. Frequency of Response: Annually. Affected Public: Individuals or households and health care providers. Type of Respondents: Study participants, next-of-kin, and physician's office staff. The annual reporting burden is as follows:
Submission for OMB Review; Comment Request (30-Day FRN): The Agricultural Health Study: A Prospective Cohort Study of Cancer and Other Disease Among Men and Women in Agriculture (NCI)
Document Number: 2013-02503
Type: Notice
Date: 2013-02-05
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 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 December 6, 2012 (Vol. 77, p. 72871) and allowed 60 days for public comment. No public comments have been 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. Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the Attention: NIH Desk Officer, Office of Management and Budget, at OIRA_ submission@omb.eop.gov or by fax to 202-395-6974. To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact Jane Hoppin, Sc.D., Epidemiology Branch, National Institute of Environmental Health Sciences, NIH, 111 T.W. Alexander Drive, PO Box 12233, MD A3-05, Research Triangle Park, NC 27709, or call non-toll-free number 919-541- 7622, or email your request, including your address to: hoppin1@niehs.nih.gov. Comments regarding this information collection are best assured of having their full effect if received within 30 days of the date of this publication. Proposed Collection: The Agricultural Health Study: A Prospective Cohort Study of Cancer and Other Disease Among Men and Women in Agriculture, 0925-0406, Expiration Date 5/31/2013REVISIONNational Institute of Environmental Health Sciences (NIEHS), National Institutes of Health (NIH). Need and Use of Information Collection: The purpose of this information collection is to continue and complete updating the occupational and environmental exposure information as well as medical history information for licensed pesticide applicators and their spouses enrolled in the Agricultural Health Study. This represents a request to complete phase IV (2013-2015) of the study and to continue and complete the buccal cell collection and the Study of Biomarkers of Exposures and Effects in Agriculture (BEEA). The primary objectives of the study are to determine the health effects resulting from occupational and environmental exposures in the agricultural environment. The phase IV follow up data will be collected by using one of three methods of the cohort member's choosing: Self-administered computer assisted Web survey (CAWI); self-administered paper-and-pen (Paper/pen); or an interviewer administered computer assisted telephone interview (CATI). Proxy interviews for those cohort members unable to complete the follow up will be completed by using one of the three methods as well. Secondary objectives include evaluating biological markers that may be associated with agricultural exposures and risk of certain types of cancer. Questionnaire data will be collected by using computer assisted telephone interview (CATI) and in-person interview (CAPI) systems for telephone screeners and home visit interviews, respectively. Some respondents will also be asked to participate in the collection of biospecimens including blood, urine, and buccal cells (loose cells from the respondent's mouth). The findings will provide valuable information concerning the potential link between agricultural exposures and cancer and other chronic diseases among agricultural Health Study cohort members, and this information may be generalized to the entire agricultural community. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 10,465.
Establishment of the 2015 Dietary Guidelines Advisory Committee
Document Number: 2013-02502
Type: Notice
Date: 2013-02-05
Agency: Department of Health and Human Services
The U.S. Department of Health and Human Services announces establishment of the 2015 Dietary Guidelines Advisory Committee (hereafter referred to as the Committee or 2015 DGAC). The 2015 DGAC is an expert advisory committee that has been established to assist the Department of Health and Human Services (HHS) and the U.S. Department of Agriculture (USDA) perform a single, time-limited task.
Rodenticides; Notice of Intent To Cancel Registrations of, and Notice of Denial of Applications for, Certain Rodenticide Bait Products
Document Number: 2013-02500
Type: Notice
Date: 2013-02-05
Agency: Environmental Protection Agency
Pursuant to section 6(b) of the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), EPA hereby announces its intent to cancel the registration of 12 rodenticide products identified in this Notice. Pursuant to section 3(c)(6) of FIFRA, EPA hereby announces the denial of applications for registration of 2 products identified in this Notice. This Notice summarizes EPA's basis for these actions, and explains how eligible persons may request a hearing and the consequences of requesting or failing to request such a hearing.
Approval and Promulgation of Implementation Plans; Texas; Revisions to New Source Review (NSR) State Implementation Plan (SIP); Emergency Orders
Document Number: 2013-02499
Type: Proposed Rule
Date: 2013-02-05
Agency: Environmental Protection Agency
EPA is proposing disapproval of revisions to the SIP for the State of Texas that relate to Emergency Orders. This includes portions of SIP revisions that relate to Emergency Orders that were submitted by Texas on August 31, 1993; December 10, 1998; February 1, 2006; and July 17, 2006. EPA is proposing disapproval of these revisions because these regulations do not meet the requirement of the Clean Air Act (the ``Act'' or ``CAA''), EPA regulations, and applicable policy and guidance. EPA is proposing this action under section 110 and parts C and D of Title I of the Act. EPA is returning the non-air portions of the aforementioned SIP submittals to the State because these provisions cannot be included in the SIP.
Partial Disapproval of State Implementation Plan; Arizona; Regional Haze Requirements
Document Number: 2013-02498
Type: Proposed Rule
Date: 2013-02-05
Agency: Environmental Protection Agency
EPA is proposing to disapprove in part revisions to the Arizona State Implementation Plan (SIP) to implement the regional haze program addressing visibility impairment in mandatory Class I areas covered by the requirements related to the Grand Canyon Visibility Transport Commission, an optional program for certain western states. These SIP revisions were submitted to address the requirements of the Clean Air Act (CAA or Act) requiring states to prevent any future and remedy any existing impairment of visibility in mandatory Class I areas caused by man-made pollution. We are taking comments on this proposal and plan to follow with a final action.
Criteria Used To Order Administrative Detention of Food for Human or Animal Consumption
Document Number: 2013-02497
Type: Rule
Date: 2013-02-05
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is issuing a final regulation that adopts, without change, the interim final rule (IFR) entitled ``Criteria Used to Order Administrative Detention of Food for Human or Animal Consumption'' that published in the Federal Register on May 5, 2011, (the 2011 IFR). This final rule affirms the IFR's change to the criteria for ordering administrative detention of human or animal food as required by the FDA Food Safety Modernization Act (FSMA). Under the new criteria, FDA can order an administrative detention if there is reason to believe that an article of food is adulterated or misbranded. This final rule does not make any changes to the regulatory requirements established by the IFR. The final regulation also responds to comments submitted in response to the request for comments in the IFR.
Combined Notice of Filings #1
Document Number: 2013-02496
Type: Notice
Date: 2013-02-05
Agency: Department of Energy, Federal Energy Regulatory Commission
Request for Nominations of Experts to the EPA Office of Research and Development's Board of Scientific Counselors
Document Number: 2013-02495
Type: Notice
Date: 2013-02-05
Agency: Environmental Protection Agency
The U.S. Environmental Protection Agency (EPA) is seeking nominations for technical experts to serve on its Board of Scientific Counselors (BOSC), a federal advisory committee to the Office of Research and Development (ORD). Submission of nominations is preferred via the BOSC Web site at: https://www.epa.gov/osp/bosc/nomination.htm.
Combined Notice of Filings #1
Document Number: 2013-02494
Type: Notice
Date: 2013-02-05
Agency: Department of Energy, Federal Energy Regulatory Commission
Combined Notice of Filings
Document Number: 2013-02493
Type: Notice
Date: 2013-02-05
Agency: Department of Energy, Federal Energy Regulatory Commission
Adequacy Status of Motor Vehicle Emission Budgets for Transportation Conformity Purposes; Connecticut
Document Number: 2013-02492
Type: Notice
Date: 2013-02-05
Agency: Environmental Protection Agency
In this notice, EPA is notifying the public that EPA has found that the 2017 and 2025 motor vehicle emissions budgets (MVEBs) in the June 22, 2012 Connecticut State Implementation Plan (SIP) revision are adequate for transportation conformity purposes. The submittal includes MOVES2010 motor vehicle emissions budgets for 2017 and 2025 for the Connecticut portion of the New York-Northern New Jersey-Long Island, NY-NJ-CT fine particle (PM2.5) nonattainment area. On March 2, 1999, the D.C. Circuit Court ruled that budgets in submitted SIPs cannot be used for conformity determinations until EPA has affirmatively found them adequate. As a result of our finding, the State of Connecticut can use the MOVES2010 motor vehicle emissions budgets from the submitted plan for future conformity determinations for the Connecticut portion of the New York-Northern New Jersey-Long Island, NY-NJ-CT PM2.5 area.
Bureau of Political-Military Affairs; Statutory Debarment Under the Arms Export Control Act and the International Traffic in Arms Regulations
Document Number: 2013-02491
Type: Notice
Date: 2013-02-05
Agency: Department of State
Notice is hereby given that the Department of State has imposed statutory debarment pursuant to Sec. 127.7(c) of the International Traffic in Arms Regulations (``ITAR'') (22 CFR parts 120 to 130) on persons convicted of violating, or conspiracy to violate, Section 38 of the Arms Export Control Act, as amended, (``AECA'') (22 U.S.C. 2778). Further, a public notice was published in the Federal Register on Tuesday, July 24, 2012, listing persons statutorily debarred pursuant to the ITAR; this notice makes one correction to that notice.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2013-02490
Type: Notice
Date: 2013-02-05
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2013-02488
Type: Notice
Date: 2013-02-05
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Findings of Research Misconduct
Document Number: 2013-02487
Type: Notice
Date: 2013-02-05
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: Bryan William Doreian, Ph.D., Case Western Reserve University: Based on the admission of the Respondent, ORI found that Dr. Bryan William Doreian, former postdoctoral fellow, Department of Dermatology, Case Western Reserve University (CWRU), engaged in research misconduct in research supported by National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH), grant T32 HL07887 and National Institute of Neurological Disorders and Stroke (NINDS), NIH, grant R01 NS052123. ORI found that the Respondent engaged in research misconduct by falsifying data that were included in: Doreian, B.W. ``Molecular Regulation of the Exocytic Mode in Adrenal Chromaffin Cells.'' Submitted in partial fulfillment of the requirements for the degree of Doctor of Philosophy, August 2009; hereafter referred to as the ``Dissertation.'' Doreian, B.W., Fulop, T.G., Meklemburg, R.L., Smith, C.B. ``Cortical F-actin, the exocytic mode, and neuropeptide release in mouse chromaffin cells is regulated by myristoylated alanine-rich C- kinase substrate and myosin II.'' Mol Biol Cell. 20(13):3142-54, 2009 Jul; hereafter referred to as the ``Mol Biol Cell paper.'' Doreian, B.W., Rosenjack, J., Galle, P.S., Hansen, M.B., Cathcart, M.K., Silverstein, R.L., McCormick, T.S., Cooper, K.D., Lu, K.Q. ``Hyper-inflammation and tissue destruction mediated by PPAR- [gamma] activation of macrophages in IL-6 deficiency.'' Manuscript prepared for submission to Nature Medicine; hereafter referred to as the ``Nature Medicine manuscript.'' As a result of the Respondent's admission, the Respondent will request that the following paper be retracted: Mol Biol Cell. 20(13):3142-54, 2009 Jul. ORI finds that Respondent falsified numerical values in the Mol Biol Cell paper, the submitted Nature Medicine manuscript, and the Dissertation by altering the number of samples or the experimental results to improve the statistical results. Specifically, ORI finds that Respondent: 1. Falsified the quantification of immunofluorescence for the ratio of phosphorylated to unphosphorylated MARCKS protein in response to different stimuli in Figure 2 of the Mol Biol Cell paper and in Figure 12 of the Dissertation by falsifying the sample number as n=15. 2. Falsified the quantification of immunofluorescence for filamentous actin in response to different stimuli in Figure 3 of the Mol Biol Cell paper and in Figure 13 of the Dissertation by falsifying the sample number as n=15. 3. Falsified the quantification for the effect of blebbistatin on catecholamine release as determined by patch clamp analysis in Figure 22 of the Dissertation by stating that 14 cells had been assayed when only 8 cells had been assayed. 4. Falsified the Pearson's cross-correlation analysis in Figure 7 of the Mol Biol Cell paper and in Figure 25 of the Dissertation, used to calculate the degree of spatial correlation between pan-chromogranin A/B (CgA/B) and the endosomal membrane, by stating that 20 or more cells had been tested for each condition when only 9-18 cells had been tested for each condition. 5. Falsified RT-PCR values for iNOS and TNF-alpha expression recorded on spreadsheets and presented in Figures 5e and 5f of the Nature Medicine manuscript showing the effect of hyper-inflammatory macrophage generation on tissue destruction, by falsifying the numeric values to fit the hypothesis of the manuscript. 6. Falsified ELISA graphs for the concentration of TNF-[alpha] in the aAB IL-6 mice and their controls in Figure 6j of the Nature Medicine manuscript showing the effect of rosiglitazone treatment in the mice, by multiplying the experimental values by 100 to match the magnitude of the values presented in Figures 21, 6h, and 6i of the Nature Medicine manuscript. 7. Falsified the RT-PCR results presented in the Nature Medicine manuscript for quantification of iNOS and TNF-[alpha] RNA expression by claiming that the results represent the rmean of three identical experiments when the three experiments were normalized differently to yield the desired result. Specifically, false results were presented for peritoneal macrophages treated in vivo with rosiglitazone and/or inhibitors of PPAR[gamma] signaling Figures 1g, 1h, and 1i, and for iNOS RNA expresssion in IL6-/- macrophages treated in vitro with either SOCS3 antisense oligonucleotides in Figure 2g or the STAT3 decoy in Figure 2j. Dr. Doreian has entered into a Voluntary Settlement Agreement and has voluntarily agreed for a period of three (3) years, beginning on January 15, 2013: (1) To have his research supervised; Respondent agreed that prior to the submission of an application for U.S. Public Health Service (PHS) support for a research project on which his participation is proposed and prior to his participation in any capacity on PHS- supported research, Respondent shall ensure that a plan for supervision of his duties is submitted to ORI for approval; the supervision plan must be designed to ensure the scientific integrity of his research contribution; he agreed that he shall not participate in any PHS- supported research until such a supervision plan is submitted to and approved by ORI; Respondent agreed to maintain responsibility for compliance with the agreed upon supervision plan; (2) That any institution employing him shall submit, in conjunction with each application for PHS funds, or report, manuscript, or abstract involving PHS-supported research in which Respondent is involved, a certification to ORI that the data provided by Respondent are based on actual experiments or are otherwise legitimately derived and that the data, procedures, and methodology are accurately reported in the application, report, manuscript, or abstract; (3) To exclude himself voluntarily 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; and (4) To request that the following paper be retracted: Mol Biol Cell. 20(13):3142-54, 2009 Jul.
Advisory Committee on Earthquake Hazards Reduction Meeting
Document Number: 2013-02486
Type: Notice
Date: 2013-02-05
Agency: Department of Commerce, National Institute of Standards and Technology
The Advisory Committee on Earthquake Hazards Reduction (ACEHR or Committee), will hold an open meeting via teleconference on Thursday, February 28, 2013 from 3 p.m. to 5 p.m. Eastern Time. The primary purpose of this meeting is to finalize the Committee's draft letter report to the NIST Director. Any draft meeting materials will be posted prior to the meeting on the National Earthquake Hazards Reduction Program (NEHRP) web site at https://nehrp.gov/. Interested members of the public will be able to participate in the meeting from remote locations by calling into a central phone number.
Acceptance of Concurrent Jurisdiction
Document Number: 2013-02483
Type: Notice
Date: 2013-02-05
Agency: Department of the Interior, National Park Service
On behalf of the United States, the National Park Service has accepted concurrent legislative jurisdiction from the State of Washington over lands and waters administered by the National Park Service within the boundaries of Lake Roosevelt National Recreation Area.
Notice of Intent To Prepare an Environmental Impact Statement for Personal Watercraft Use at Gulf Islands National Seashore, Florida and Mississippi
Document Number: 2013-02482
Type: Notice
Date: 2013-02-05
Agency: Department of the Interior, National Park Service
Pursuant to Section 102(2)(c) of the National Environmental Policy Act of 1969, 42 U.S.C. 4332(2)(C), the National Park Service (NPS) is preparing an Environmental Impact Statement (EIS) to analyze the impacts of Personal Watercraft (PWC) use at Gulf Islands National Seashore (GUIS). Personal Watercraft use emerged at GUIS in the 1980s and was permitted in units of the national park system under the same regulations as other motorized watercraft. However, on March 21, 2000, the NPS published a regulation governing PWC use within all units of the national park system (65 FR 15077, codified at 36 CFR 3.24). This regulation prohibits PWC use in all national park units unless the NPS determines that this type of water-based recreational activity is appropriate for the specific park unit based on the legislation establishing that park, the park's resources and values, other visitor uses of the area, and overall management objectives. In 2004, the NPS prepared an Environmental Assessment (EA) for a special regulation to allow continued PWC use at GUIS. The purpose of the EA was to evaluate a range of alternatives and strategies for the management of PWC use at GUIS to ensure the protection of park resources and values, while offering recreational opportunities as provided for in the GUIS enabling legislation, purpose, mission, and goals. A Finding of No Significant Impact (FONSI) was signed on January 25, 2006. The NPS published the final regulation for PWC use at GUIS in the Federal Register on May 4, 2006 (71 FR 26232). On May 15, 2008, a lawsuit was filed claiming that the PWC EA was deficient and violated NEPA, the NPS Organic Act, and the Administrative Procedure Act. On July 8, 2010, the U.S. District Court for the District of Columbia found that the impact analysis in the EA was inadequate. The court did not vacate the current PWC rule at GUIS, but remanded the case to the NPS ``so that it may have an opportunity to provide adequate reasoning for its conclusions.'' The special regulation remains in effect at GUIS and PWC are currently still allowed to operate under the restrictions identified in the park's special regulation. At this time, the NPS intends to address the deficiencies identified by the court by preparing an EIS for PWC use at GUIS, which will include supplemental documentation, impact analyses not present in the earlier EA, and may include additional alternatives.
Meeting of the Joint ACRS Subcommittees on Thermal Hydraulic Phenomena and Materials, Metallurgy and Reactor Fuels; Notice of Meeting
Document Number: 2013-02481
Type: Notice
Date: 2013-02-05
Agency: Nuclear Regulatory Commission, Agencies and Commissions, Advisory Committee on Reactor Safeguards (acrs)
National Institutes of Health
Document Number: 2013-02480
Type: Notice
Date: 2013-02-05
Agency: Department of Health and Human Services
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Heart, Lung, and Blood Institute (NHLBI), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval the information collection listed below. This proposed information collection was previously published in the Federal Register in Volume 77, No. 199/Monday, October 15, 2012, pages 62518- 62519, and allowed 60-days for public comment. No comments have been 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: Title: Recipient Epidemiology and Donor Evaluation Study-III (REDS-III). Type of Information Collection Request: New. Need and Use of Information Collection: The objective of the Recipient Epidemiology and Donor Evaluation Study-III (REDS-III) program is to ensure safe and effective blood banking and transfusion medicine practices through a comprehensive, multifaceted strategy involving basic, translational, and clinical research to improve the benefits of transfusion while reducing its risks. The conduct of epidemiologic, survey, and laboratory studies is the cornerstone of REDS-III and its predecessors, the REDS and REDS-II programs. Over the past 20 years, the National Heart, Lung, and Blood Institute (NHLBI) REDS programs have proven to be the premier research programs in blood collection and transfusion safety in the United States. Successive renditions of the REDS programs have built upon the many successes that this research network has realized over the years while being responsive to changing research and clinical needs, and adapting to emerging priorities. Research findings have served to improve the screening of donors and collected blood products, blood banking practices, diagnoses, and the basic science principles of transfusion medicine. While significant progress has been made, transfusion therapya very commonly used therapy affecting about six million recipients annually in the U.S.remains one of the least understood medical procedures. REDS-II conducted studies of blood donor health but much more needs to be learned, including how donor genetic or environmental factors may affect the quality of collected blood components and influence non-infectious transfusion complications in recipients. Additionally, there is always the potential that a new, emerging or re- emerging infection may pose a threat to the safety of the U.S. blood supply. Much of the success of the REDS programs was due to their ability to respond in a timely fashion to potential blood safety threats such as West Nile Virus (WNV) in 2002 or Xenotropic Murine Leukemia Virus Related Virus (XMRV) in 2009. Globally, the threat of HIV and other blood-borne infections to blood safety remains real and has to be closely monitored. Therefore, continuing collection of new scientific evidence through REDS-III is both critical to public health in the U.S. and to countries struggling with the HIV epidemic where blood safety and availability are major concerns. Additionally, the research areas encompassed in REDS-III have been and continue to be hypothesis generating, leading to the development of new basic and translational research projects with implications well beyond the fields of blood banking and transfusion medicine. REDS-III has also been charged with the tasks of education and training and integration of these components in a transfusion medicine research network. With this submission, the REDS-III Study seeks approval from OMB to develop research studies with data collection activities using focus groups, cognitive interviews, questionnaires and/or qualitative interviews following all required informed consent procedures for respondents and parents/caregivers as appropriate. With this generic clearance, study investigators will be able to use the OMB-approved data collection methods where appropriate to plan and implement time sensitive studies. Such studies that fall within the overall scope of this submission will be subjected to expedited review and approval by OMB before their implementation. Additionally, studies are reviewed by an NHLBI Observational Study Monitoring Board (OSMB) and by all relevant IRBs. Frequency of Response: Once. Affected Public: Individuals. Type of Respondents: Males and females 16 years old or older. The annual reporting burden is as follows: Estimated Number of Respondents: 6,882; Estimated Number of Responses per Respondent: Focus Groups: 1 per respondent; Cognitive Interviews: 2 per respondent; Respondent Surveys: 3 per respondent. Average Burden of Hours per Response: Focus Groups: 1.5 hours per respondent; Cognitive Interviews: 1 hour per respondent; Respondent Surveys: 20 minutes per respondent Estimated Total Annual Burden Hours Requested: 7,532. The annualized total costs to all respondents are $66,288. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report.
Advisory Committee on Reactor Safeguards (ACRS); Meeting of the ACRS Subcommittee on US-APWR; Notice of Meeting
Document Number: 2013-02478
Type: Notice
Date: 2013-02-05
Agency: Nuclear Regulatory Commission, Agencies and Commissions
Spent Fuel Cask Certificate of Compliance Format and Content
Document Number: 2013-02477
Type: Proposed Rule
Date: 2013-02-05
Agency: Nuclear Regulatory Commission, Agencies and Commissions
The U.S. Nuclear Regulatory Commission (NRC) is publishing for public comment a notice of receipt for a petition for rulemaking (PRM), dated October 3, 2012, which was filed with the NRC by Anthony R. Pietrangelo on behalf of the Nuclear Energy Institute (NEI or the petitioner). The petition was docketed by the NRC on October 18, 2012, and assigned Docket No. PRM-72-7. The petitioner requests that the NRC add a new rule that governs the format and content of spent fuel storage cask Certificates of Compliance (CoCs), extend the backfit rule to CoCs, and make other improvements that result in ``more efficient and effective NRC oversight of dry cask storage activities as well as improved implementation of dry cask storage requirements by industry.''
Notice of Release From Quitclaim Deed and Federal Grant Assurance Obligations for Delano Municipal Airport, Delano, CA
Document Number: 2013-02475
Type: Notice
Date: 2013-02-05
Agency: Federal Aviation Administration, Department of Transportation
The Federal Aviation Administration (FAA) proposes to rule and invites public comment on the application for a release of approximately 9.89 acres of airport property at Delano Municipal Airport, Delano, California from all conditions contained in the Quitclaim Deed and Grant Assurances since the parcels of land are not needed for airport purposes. The property will be conveyed at its fair market value for the benefit of the airport. The use of the land by the City of Delano will remain the same and represents a continued compatible land use that will not interfere with the airport or its operation, thereby protecting the interests of civil aviation.
Actions Taken Pursuant to Executive Order 13382
Document Number: 2013-02474
Type: Notice
Date: 2013-02-05
Agency: Department of the Treasury, Office of Foreign Assets Control
The Treasury Department's Office of Foreign Assets Control (``OFAC'') is publishing on OFAC's list of Specially Designated Nationals and Blocked Persons (``SDN List'') the names of three entities and three individuals, whose property and interests in property are blocked pursuant to Executive Order 13382 of June 28, 2005, ``Blocking Property of Weapons of Mass Destruction Proliferators and Their Supporters.'' The designations by the Director of OFAC, pursuant to Executive Order 13382, were effective on January 24, 2013.
Certain Wireless Devices With 3G and/or 4G Capabilities and Components Thereof; Institution of Investigation Pursuant to 19 U.S.C. 1337
Document Number: 2013-02473
Type: Notice
Date: 2013-02-05
Agency: International Trade Commission, Agencies and Commissions
Notice is hereby given that a complaint was filed with the U.S. International Trade Commission on January 2, 2013, under section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337, on behalf of InterDigital Communications, Inc. of King of Prussia, Pennsylvania; InterDigital Technology Corporation of Wilmington, Delaware; IPR Licensing, Inc. of Wilmington, Delaware; and InterDigital Holdings, Inc. of Wilmington, Delaware. The complaint alleges violations of section 337 based upon the importation into the United States, the sale for importation, and the sale within the United States after importation of certain wireless devices with 3G and/or 4G capabilities and components thereof by reason of infringement of certain claims of U.S. Patent No. 7,190,966 (``the `966 patent''); U.S. Patent No. 7,286,847 (``the `847 patent''); U.S. Patent No. 8,009,636 (``the `636 patent''); U.S. Patent No. 7,706,830 (``the `830 patent''); U.S. Patent No. 7,941,151 (``the `151 patent''); U.S. Patent No. 7,616,970 (``the `970 patent''); and U.S. Patent No. 7,502,406 (``the `406 patent''). The complaint further alleges that an industry in the United States exists as required by subsection (a)(2) of section 337. The complainants request that the Commission institute an investigation and, after the investigation, issue an exclusion order and cease and desist orders.
Actions Taken Pursuant to Executive Order 13382
Document Number: 2013-02472
Type: Notice
Date: 2013-02-05
Agency: Department of the Treasury, Office of Foreign Assets Control
The Treasury Department's Office of Foreign Assets Control (``OFAC'') is announcing an update to the entry of an entity on OFAC's SDN List by adding an alias to the entity's entry. The addition of the alias by the Director of OFAC, pursuant to Executive Order 13382, is effective on January 24, 2013.
Codex Alimentarius Commission: Meeting of the Codex Committee on Food Additives
Document Number: 2013-02470
Type: Notice
Date: 2013-02-05
Agency: Department of Agriculture, Food Safety and Inspection Service
The Office of the Acting Under Secretary for Food Safety, U.S. Department of Agriculture (USDA), and the Food and Drug Administration (FDA), U.S. Department of Health and Human Services, is sponsoring a public meeting on February 11, 2013, from 9:00 a.m. to 12:00 p.m. The objective of the public meeting is to provide information and receive public comments on agenda items and draft United States (U.S.) positions that will be discussed at the 45th Session of the Codex Committee on Food Additives (CCFA) of the Codex Alimentarius Commission (Codex), which will be held in Beijing, China March 18-22, 2013. USDA and FDA recognize the importance of providing interested parties the opportunity to obtain background information on the 45th Session of the CCFA and to address items on the agenda.
Establishment of the Elkton Oregon Viticultural Area
Document Number: 2013-02468
Type: Rule
Date: 2013-02-05
Agency: Alcohol and Tobacco Tax and Trade Bureau, Department of Treasury, Department of the Treasury
The Alcohol and Tobacco Tax and Trade Bureau (TTB) establishes the approximately 74,900-acre ``Elkton Oregon'' viticultural area in Douglas County, Oregon. The viticultural area lies totally within the Umpqua Valley viticultural area and the multi-county Southern Oregon viticultural area. TTB designates viticultural areas to allow vintners to better describe the origin of their wines and to allow consumers to better identify wines they may purchase.
Application for Final Commitment for a Long-Term Loan or Financial Guarantee in Excess of $100 million: AP086911XX and AP087599XX
Document Number: 2013-02467
Type: Notice
Date: 2013-02-05
Agency: Export-Import Bank of the United States
This Notice is to inform the public, in accordance with Section 3(c)(10) of the Charter of the Export-Import Bank of the United States (``Ex-Im Bank''), that Ex-Im Bank has received an application for final commitment for a long-term loan or financial guarantee in excess of $100 million (as calculated in accordance with Section 3(c)(10) of the Charter). Comments received within the comment period specified below will be presented to the Ex-Im Bank Board of Directors prior to final action on this Transaction. Reference: AP086911XX and AP087599XX. Purpose and Use: Brief description of the purpose of the transaction: To support the export of U.S. manufactured commercial aircraft to Israel. Brief non-proprietary description of the anticipated use of the items being exported: To be used for short-haul passenger air service between Israel and destinations in Europe. To the extent that Ex-Im Bank is reasonably aware, the item(s) being exported are not expected to produce exports or provide services in competition with the exportation of goods or provision of services by a United States industry. Parties: Principal Supplier: The Boeing Company. Obligor: EL AL Israel Airlines, Ltd. Guarantor(s): N/A. Description of Items Being Exported: Boeing 737 aircraft. Information on Decision: Information on the final decision for this transaction will be available in the ``Summary Minutes of Meetings of Board of Directors'' on https://www.exim.gov/articles.cfm/ board%20minute. Confidential Information: Please note that this notice does not include confidential or proprietary business information; information which, if disclosed, would violate the Trade Secrets Act; or information which would jeopardize jobs in the United States by supplying information that competitors could use to compete with companies in the United States.
Application for Final Commitment for a Long-Term Loan or Financial Guarantee in Excess of $100 million: AP078791XX
Document Number: 2013-02466
Type: Notice
Date: 2013-02-05
Agency: Export-Import Bank of the United States
This Notice is to inform the public, in accordance with Section 3(c)(10) of the Charter of the Export-Import Bank of the United States (``Ex-Im Bank''), that Ex-Im Bank has received an application for final commitment for a long-term loan or financial guarantee in excess of $100 million (as calculated in accordance with Section 3(c)(10) of the Charter). Comments received within the comment period specified below will be presented to the Ex-Im Bank Board of Directors prior to final action on this Transaction. Reference: AP078791XX Purpose and Use: Brief description of the purpose of the transaction: To support the export of U.S. manufactured commercial aircraft to Morocco. Brief non-proprietary description of the anticipated use of the items being exported: To be used for medium-haul passenger air service between Morocco and destinations in Europe, Africa and the Middle East. To the extent that Ex-Im Bank is reasonably aware, the item(s) being exported are not expected to produce exports or provide services in competition with the exportation of goods or provision of services by a United States industry. Parties: Principal Supplier: The Boeing Company Obligor: Compagnie Nationale Royal Air Maroc Guarantor(s): N/A Description of Items Being Exported: Boeing 737 aircraft. Information on Decision: Information on the final decision for this transaction will be available in the ``Summary Minutes of Meetings of Board of Directors'' on https://www.exim.gov/articles.cfm/ board%20minute. Confidential Information: Please note that this notice does not include confidential or proprietary business information; information which, if disclosed, would violate the Trade Secrets Act; or information which would jeopardize jobs in the United States by supplying information that competitors could use to compete with companies in the United States.
Application for Final Commitment for a Long-Term Loan or Financial Guarantee in Excess of $100 Million: AP087679XX
Document Number: 2013-02463
Type: Notice
Date: 2013-02-05
Agency: Export-Import Bank, Agencies and Commissions
This Notice is to inform the public, in accordance with Section 3(c)(10) of the Charter of the Export-Import Bank of the United States (``Ex-Im Bank''), that Ex-Im Bank has received an application for final commitment for a long-term loan or financial guarantee in excess of $100 million (as calculated in accordance with Section 3(c)(10) of the Charter). Comments received within the comment period specified below will be presented to the Ex-Im Bank Board of Directors prior to final action on this Transaction. Reference: AP087679XX. Purpose and Use: Brief description of the purpose of the transaction: To support the export of U.S.-manufactured cargo aircraft to Dubai, the United Arab Emirates. Brief non-proprietary description of the anticipated use of the items being exported: To provide cargo services globally. To the extent that Ex-Im Bank is reasonably aware, the item(s) being exported may be used to produce exports or provide services in competition with the exportation of goods or provision of services by a United States industry. Parties: Principal Supplier: The Boeing Company. Obligor: Dubai Aerospace Enterprise. Guarantor(s): N/A. Description of Items Being Exported: Boeing 777 aircraft. Information on Decision: Information on the final decision for this transaction will be available in the ``Summary Minutes of Meetings of Board of Directors'' on https://www.exim.gov/articles.cfm/ board%20minute. Confidential Information: Please note that this notice does not include confidential or proprietary business information; information which, if disclosed, would violate the Trade Secrets Act; or information which would jeopardize jobs in the United States by supplying information that competitors could use to compete with companies in the United States.
Formations of, Acquisitions by, and Mergers of Bank Holding Companies
Document Number: 2013-02462
Type: Notice
Date: 2013-02-05
Agency: Federal Reserve System, Agencies and Commissions
Proposed Flood Elevation Determinations
Document Number: 2013-02461
Type: Proposed Rule
Date: 2013-02-05
Agency: Federal Emergency Management Agency, Department of Homeland Security
On November 29, 2011 and November 9, 2012, FEMA published in the Federal Register a proposed rule and a correction to the proposed rule that contained erroneous tables. This notice provides corrections to those tables, to be used in lieu of the information published at 76 FR 73537 and 76 FR 67325. The table provided here represents the flooding sources, location of referenced elevations, effective and modified elevations, and communities affected for Sullivan County, Pennsylvania (All Jurisdictions). Specifically, it addresses the flooding sources Big Run, Little Loyalsock Creek, Loyalsock Creek, and Muncy Creek.
Cancellation of the Notice of Intent To Prepare a Draft and Final Supplemental Environmental Impact Statement for Reach 1B, C, and D on the Herbert Hoover Dike Major Rehabilitation Project, Martin and Palm Beach Counties
Document Number: 2013-02460
Type: Notice
Date: 2013-02-05
Agency: Department of Defense, Department of the Army, Corps of Engineers
The Jacksonville District, U.S. Army Corps of Engineers (USACE) hereby cancels its Notice of Intent (NOI) to prepare a Supplemental Environmental Impact Statement (SEIS) for Reach 1B, C, and D on the HHD Major Rehabilitation Project, as published in the Federal Register, July 28, 2009 (74 FR 37190). The cancellation of the subject SEIS is necessitated due to a change in scope of the rehabilitation project. The initial focus of the HHD Major Rehabilitation Report (MRR) from 2000 divided the 143 miles dike into eight Reaches with the initial focus on Reach 1. This Reach by Reach approach is being replaced with a system-wide risk reduction approach as required for safety modifications to dams.
Cancellation of the Notice of Intent To Prepare a Draft and Final Supplemental Environmental Impact Statement for Reach 1A on the Herbert Hoover Dike Major Rehabilitation Project, Martin and Palm Beach Counties
Document Number: 2013-02459
Type: Notice
Date: 2013-02-05
Agency: Department of Defense, Department of the Army, Corps of Engineers
The Jacksonville District, U.S. Army Corps of Engineers (USACE) hereby cancels its Notice of Intent (NOI) to prepare a Supplemental Environmental Impact Statement (SEIS) for Reach 1A on the Herbert Hoover Dike (HHD) Major Rehabilitation Project, as published in the Federal Register, March 9, 2009 (74 FR 10038). The USACE issued a Notice of Availability (NOA) for the Draft SEIS on June 25, 2010 (75 FR 36386). A public meeting was held in Canal Point on July 22, 2010 to present the Draft SEIS. The cancellation of the subject SEIS is necessitated due to a change in scope of the rehabilitation project. The initial focus of the HHD Major Rehabilitation Report (MRR) from 2000 divided the 143 miles dike into eight Reaches with the initial focus on Reach 1. This Reach by Reach approach is being replaced with a system-wide risk reduction approach as required for safety modifications to dams.
Cancellation of the Notice of Intent To Prepare a Draft and Final Supplemental Environmental Impact Statement for Reaches 2 and 3 on the Herbert Hoover Dike Major Rehabilitation Project, Palm Beach and Glades Counties, FL
Document Number: 2013-02458
Type: Notice
Date: 2013-02-05
Agency: Department of Defense, Department of the Army, Corps of Engineers
The Jacksonville District, U.S. Army Corps of Engineers (USACE) hereby cancels its Notice of Intent (NOI) to prepare a Supplemental Environmental Impact Statement (SEIS) for Reaches 2 and 3 on the HHD Major Rehabilitation Project, as published in the Federal Register, August 9, 2006 (71 FR 45539). The USACE issued an NOA for the Draft SEIS on December 22, 2006 (71 FR 77013). A public meeting was held in Clewiston on January 10, 2007 to present the Draft SEIS. The USACE issued a second NOI, published in the Federal Register, August 31, 2009 (74 FR 44828), due to a revision to the preferred alternative discussed and coordinated in the December 2006 Draft SEIS. The cancellation of the subject SEIS is necessitated due to a change in scope of the rehabilitation project. The initial focus of the HHD Major Rehabilitation Report (MRR) from 2000 divided the 143 miles dike into eight Reaches with the initial focus on Reach 1. This Reach by Reach approach is being replaced with a system wide risk reduction approach as required for safety modifications to dams.
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