November 9, 2015 – Federal Register Recent Federal Regulation Documents

The National Museum and Library Services Board, which advises the Director of the Institute of Museum and Library Services on general policies with respect to the duties, powers, and authority of the Institute relating to museum, library and information services, will meet on November 18, 2015.

In accordance with Section 122(i) of the Comprehensive Environmental Response Compensation, and Liability Act, as amended (``CERCLA''), 42 U.S.C. Section 9622(i), notice is hereby given of a proposed administrative settlement for recovery of response costs under CERCLA Sections 122(h) and 104(e), concerning the RBF Frozen Desserts Superfund Site in West Hartford, Connecticut with the following settling party: RBF Frozen Desserts, LLC. The settlement requires the RBF Frozen Desserts, LLC to pay $122,518.89 to the Hazardous Substance Superfund, with interest. For 30 days following the date of publication of this notice, the Agency will receive written comments relating to the settlement. The United States will consider all comments received and may modify or withdraw its consent to the settlement if comments received disclose facts or considerations which indicate that the settlement is inappropriate, improper, or inadequate. The Agency's response to any comments received will be available for public inspection at 5 Post Office Square, Boston, MA 02109-3912.

On November 2, 2015, the U.S. Environmental Protection Agency (EPA) announced a meeting of the National Drinking Water Advisory Council (NDWAC) in the Federal Register, as authorized under the Safe Drinking Water Act. This notice announces the location of the meeting (see the ADDRESSES section of this notice). The meeting is scheduled for November 17, 18 and 19, 2015. During this meeting, the NDWAC will focus discussions on developing recommendations for the EPA Administrator on the Lead and Copper National Primary Drinking Water RegulationLong Term Revisions.

The Environmental Protection Agency (EPA) is announcing the availability, for public review, the draft document titled Draft Integrated Review Plan for the Secondary National Ambient Air Quality Standard for Oxides of Nitrogen and Oxides of Sulfur (draft IRP). This document contains the plans for the review of the air quality criteria for oxides of nitrogen and oxides of sulfur and the secondary national ambient air quality standards (NAAQS) for oxides of nitrogen and oxides of sulfur (NOX/SOX). The secondary NOX/SOX NAAQS provide for the protection of public welfare from exposure to NOX and SOX in ambient air.

The Coast Guard announces that a Certificate of Alternative Compliance was issued for the Uninspected Towing Vessel LEIGH ANN MORAN as required by statute.

The Department of Homeland Security (DHS), U.S. Citizenship and Immigration Services (USCIS) will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995. The information collection notice was previously published in the Federal Register on August 4, 2015, at 80 FR 46314, allowing for a 60-day public comment period. USCIS did receive one comment in connection with the 60-day notice.

This is an amendment of the Presidential declaration of a major disaster for Public Assistance Only for the State of Washington (FEMA-4242- DR), dated 10/15/2015. Incident: Severe Windstorm. Incident Period: 08/29/2015.

The Department of Commerce (``the Department'') has received requests to conduct administrative reviews of various antidumping and countervailing duty orders and findings with September anniversary dates. In accordance with the Department's regulations, we are initiating those administrative reviews.

On September 8, 2015, the Director of the National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC), published a notice in the Federal Register [80 FR 53802] announcing the availability of the following draft document for public comment entitled A Vapor Containment Performance Protocol for Closed System Transfer Devices Used During Pharmacy Compounding and Administration of Hazardous Drugs. Written comments were to be received by November 9, 2015. NIOSH is extending the public comment period for an additional 120 days.

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

The Department of State is seeking Office of Management and Budget (OMB) approval for the information collection described below. In accordance with the Paperwork Reduction Act of 1995, we are requesting comments on this collection from all interested individuals and organizations. The purpose of this notice is to allow 60 days for public comment preceding submission of the collection to OMB.

In accordance with the Paperwork Reduction Act of 1995, this notice announces the Rural Business-Cooperative Service's (RBS) intention to request an extension for a currently approved information collection in support of the program for 7 CFR part 4284, subpart K, Agriculture Innovation Demonstration Centers.

The Office of Management and Budget (OMB) is correcting the final guidance that appeared in the Federal Register on July 22, 2015 (80 FR 43301). OMB is amending the guidance to make technical corrections where necessary. The final guidance is revised to reflect that due to the 14 day delay of the publically available information entered into the OMB-designated integrity and performance system accessible through SAM (currently the Federal Awardee Performance and Integrity Information System (FAPIIS)), Federal awarding agencies should review the non-public segment of the system when conducting their risk review as described in the guidance. This will ensure that Federal awarding agencies have the most current information available when completing the review.

EDF Trading North America, LLC (Applicant) has applied to renew its authority to transmit electric energy from the United States to Mexico pursuant to section 202(e) of the Federal Power Act.

Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Anil Potti, M.D., Duke University School of Medicine: Based on the reports of investigations conducted by Duke University School of Medicine (Duke) and additional analysis conducted by ORI in its oversight review, ORI found that Dr. Anil Potti, former Associate Professor of Medicine, Duke, engaged in research misconduct in research supported by National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH), grant R01 HL072208 and National Cancer Institute (NCI), NIH, grants R01 CA136530, R01 CA131049, K12 CA100639, R01 CA106520, and U54 CA112952. ORI found that Respondent engaged in research misconduct by including false research data in the following published papers, submitted manuscript, grant application, and the research record as specified in 1-3 below. Specifically, ORI found that: 1. Respondent stated in grant application 1 R01 CA136530-01A1 that 6 out of 33 patients responded positively to dasatinib when only 4 patients were enrolled and none responded and that the 4 CT scans presented in Figure 14 were from the lung cancer study when they were not. 2. Respondent altered data sets to improve the accuracy of predictors for response to treatments in a submitted paper and in the research record by: Reversing the responder status of 24 out of 133 subjects for the adriamycin predictor in a manuscript submitted to Clinical Cancer Research switching the cancer recurrence phenotype for 46 out of 89 samples to validate the LMS predictor in a file provided to a colleague in 2008 changing IC-50 and R-code values for the cisplatin predictor in a data set provided to NCI in 2010 3. Respondent reported predictors and/or their validation by disregarding accepted scientific methodology so that false data were reported in the following: Blood 107:1391-1396, 2006: Describing a predictor for thrombotic phenotypes New England Journal of Medicine 355:570-580, 2006: Describing a predictor of lung cancer relapse Nature Medicine 12:1294-1300, 2006: Describing a predictor for the response to the chemotherapeutic drugs topectan and docetaxol Journal of Clinical Oncology 25:4350-4357, 2007: Describing a predictor for the response to the chemotherapeutic drug cisplatin Lancet Oncology 8:1071-1078, 2007: Describing a predictor for the response to the combination of the chemotherapeutic drugs flurouracil, epirubicin, and cyclophosphamide or docetaxol, epirubicin, and docetaxol Journal of the American Medical Association 299:1574-1587, 2008: Describing a predictor for breast cancer relapse Public Library Science One 3:e1908, 2008: Describing a predictor for the response to the chemotherapeutic drugs paclitaxel, 5- fluouracil, adriamycin, and cyclophosphamide Proceedings of the National Academy of Sciences 105:19432- 19437, 2008: Describing a predictor of colon cancer recurrence Clinical Cancer Research 15:7553-7561, 2009: Describing a predictor for the response to the chemotherapeutic drug cisplatin As a result of Duke's investigation, the published papers listed above were retracted. Respondent has entered into a Voluntary Settlement Agreement with ORI. Respondent neither admits nor denies ORI's findings of research misconduct; the settlement is not an admission of liability on the part of the Respondent. The parties entered into the Agreement to conclude this matter without further expenditure of time, finances, or other resources. Respondent has not applied for or engaged in U.S. Public Health Service (PHS)-supported research since 2010. Respondent stated that he has no intention of applying for or engaging in PHS-supported research or otherwise working with PHS. However, the Respondent voluntarily agreed: (1) That if the respondent obtains employment in a research position in which he receives or applies for PHS support within five years of the effective date of the Agreement (September 23, 2015), he shall have his research supervised for a period of five years; (2) that prior to the submission of an application for PHS support for a research project on which the Respondent's participation is proposed and prior to Respondent's participation in any capacity on PHS-supported research, Respondent shall ensure that a plan for supervision of Respondent's duties is submitted to ORI for approval; the supervision plan must be designed to ensure the scientific integrity of Respondent's research contribution; Respondent 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; (3) 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; and (4) 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 for period of five years beginning on September 23, 2015.

As required by the Privacy Act of 1974, as amended, the RRB is issuing public notice of its renewal of an ongoing computer-matching program with the Social Security Administration (SSA). The purpose of this notice is to advise individuals applying for or receiving benefits under the Railroad Retirement Act of the use made by RRB of this information obtained from SSA by means of a computer match. The RRB is also issuing public notice, on behalf of the SSA, of their intent to conduct a computer-matching program based on information provided to them by the RRB.

The Mid-Atlantic Fishery Management Council's (Council) Scientific and Statistical Committee (SSC) will hold a meeting.