April 15, 2015 – Federal Register Recent Federal Regulation Documents
Results 51 - 100 of 106
Notice To Reopen the Public Comment Period and Notice of Additional Public Meetings for the Kachess Drought Relief Pumping Plant and Keechelus Reservoir-to-Kachess Reservoir Conveyance Draft Environmental Impact Statement, Kittitas and Yakima Counties, Washington
The Bureau of Reclamation is reopening the public comment period for the Kachess Drought Relief Pumping Plant and Keechelus Reservoir-to-Kachess Reservoir Conveyance Draft Environmental Impact Statement (EIS) for another 60 days to allow the public more time to comment. We are also announcing four additional public meetings to be held in May 2015.
Endangered and Threatened Wildlife and Plants; 5-Year Status Reviews of Black-Lace Cactus, Bone Cave Harvestman, Pima Pineapple Cactus, Texas Snowbells, and Walker's Manioc in the Southwest Region
We, the U.S. Fish and Wildlife Service, are initiating 5-year status reviews under the Endangered Species Act of 1973, as amended (Act), of the endangered black-lace cactus (Echinocereus reichenbachii var. albertii), the endangered Bone Cave harvestman (Texella reyesi), the endangered Pima pineapple cactus (Coryphantha scheeri var. robustispina), the endangered Texas snowbells (Styrax texanus), and the endangered Walker's manioc (Manihot walkerae). A 5-year review is based on the best scientific and commercial data available at the time of the review; therefore, we are requesting submission of any such information that has become available since our original listing of these five species or since the last 5-year review.
Request for Nomination for Industry Representatives and Participation From Industry Organizations on Public Advisory Committees
The Food and Drug Administration (FDA) is requesting that any industry organizations interested in participating in the selection of nonvoting industry representatives to serve on its public advisory committees for the Center for Drug Evaluation and Research (CDER) notify FDA in writing. FDA is also requesting nominations for nonvoting industry representatives to serve on CDER's public advisory committees. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. Nominations will be accepted for current vacancies effective with this notice.
Regulatory Publication and Review Under the Economic Growth and Regulatory Paperwork Reduction Act of 1996
The OCC, Board, and FDIC (``Agencies'') announce the third in a series of outreach meetings on the Agencies' interagency process to review their regulations under the Economic Growth and Regulatory Paperwork Reduction Act of 1996 (``EGRPRA'').
Agency Information Collection Activities: Proposed Collection; Comment Request; User Fee Cover Sheet; Form FDA 3397
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection requirements relating to Form FDA 3397, User Fee Cover Sheet, that must be submitted along with certain drug and biologic product applications and supplements.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food and Cosmetic Export Certificate Application Process
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Determination of Regulatory Review Period for Purposes of Patent Extension; AUBAGIO-Patent No. 6,794,410
The Food and Drug Administration (FDA) has determined the regulatory review period for AUBAGIO and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Determination of Regulatory Review Period for Purposes of Patent Extension; AUBAGIO-Patent No. 5,679,709
The Food and Drug Administration (FDA) has determined the regulatory review period for AUBAGIO and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Innovations in Medical Evidence Development and Surveillance-Methods Research Agenda
The Food and Drug Administration (FDA) is announcing the availability of grant funds for the support of Center for Drug Evaluation and Research (CDER). The goal of the CDER is to support the development of appropriate methodologies to conduct medical product safety surveillance in large electronic databases. Innovations in Medical Evidence Development and Surveillance (IMEDS)-Methods is a program within the Reagan-Udall Foundation that supports FDA's scientific mission of serving public health needs by initiating and facilitating research into the methods of safety evaluation in large databases.
Proposed Agency Information Collection Activities; Submission for OMB Review; Interest-Rate-Risk Vendor Questionnaire
The OCC, as part of its continuing effort to reduce paperwork and respondent burden and to fulfill the requirements of the Paperwork Reduction Act of 1995 (PRA), invites the general public and other Federal agencies to take this opportunity to comment on a new information collection. In accordance with the requirements of the PRA, the OCC may not conduct or sponsor, and the respondent is not required to respond to, an information collection unless it displays a currently valid Office of Management and Budget (OMB) control number. Currently, the OCC is soliciting comment concerning its proposed information collection entitled, ``Interest Rate Risk Vendor Questionnaire.'' It also is giving notice that it has sent the collection to OMB for review.
Agency Information Collection Activities: Information Collection Renewal; Comment Request; Guidance on Stress Testing for Banking Organizations With More than $10 Billion in Total Consolidated Assets
The OCC, 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 continuing information collection, as required by the Paperwork Reduction Act of 1995 (PRA). In accordance with the requirements of the PRA, the OCC may not conduct or sponsor, and the respondent is not required to respond to, an information collection unless it displays a currently valid Office of Management and Budget (OMB) control number. The OCC is soliciting comment concerning renewal of its information collection titled, ``Guidance on Stress Testing for Banking Organizations with more than $10 Billion in Total Consolidated Assets.''
Submission for OMB Review; Comments Request
Under the provisions of the Paperwork Reduction Act (44 U.S.C. Chapter 35), agencies are required to publish a Notice in the Federal Register notifying the public that the agency is renewing an existing form and as such has prepared an information collection for OMB review and approval and requests public review and comment on the submission. OPIC received no comments in response to the sixty (60) day notice published in Federal Register on February 2, 2015 [80 FR 5583]. The purpose of this notice is to allow an additional thirty (30) days for public comments to be submitted. Comments are being solicited on the need for the information; the accuracy of OPIC's burden estimate; the quality, practical utility, and clarity of the information to be collected; and ways to minimize reporting the burden, including automated collected techniques and uses of other forms of technology.
Submission for OMB Review; Comments Request
Under the provisions of the Paperwork Reduction Act (44 U.S.C. Chapter 35), agencies are required to publish a Notice in the Federal Register notifying the public that the agency is renewing an existing form and as such has prepared an information collection for OMB review and approval and requests public review and comment on the submission. OPIC received no comments in response to the sixty (60) day notice published in Federal Register volume 80 page 5584 on February 2, 2015. The purpose of this notice is to allow an additional thirty (30) days for public comments to be submitted. Comments are being solicited on the need for the information; the accuracy of OPIC's burden estimate; the quality, practical utility, and clarity of the information to be collected; and ways to minimize reporting the burden, including automated collected techniques and uses of other forms of technology.
Meetings of Humanities Panel
The National Endowment for the Humanities will hold two meetings of the Humanities Panel, a federal advisory committee, during May, 2015. The purpose of the meetings is for panel review, discussion, evaluation, and recommendation of applications for financial assistance under the National Foundation on the Arts and Humanities Act of 1965.
Determination of Attainment of the 1-Hour Ozone National Ambient Air Quality Standard in the Southeast Desert Nonattainment Area in California
The Environmental Protection Agency (EPA) is determining that the Southeast Desert nonattainment area has attained the 1-hour ozone National Ambient Air Quality Standard. This determination is based on complete, quality-assured, and certified data for the most recent three-year period (2011-2013). Preliminary data available through December 2014 are consistent with continued attainment.
Information Collection; Criteria and Procedures for Emergency Access to Non-Federal and Regional Low-Level Waste Disposal Facilities
The U.S. Nuclear Regulatory Commission (NRC) has recently submitted a request for renewal of an existing collection of information to the Office of Management and Budget (OMB) for review. The information collection is entitled, ``Criteria and Procedures for Emergency Access to Non-Federal and Regional Low-Level Waste Disposal Facilities.''
Proposed Exemptions From Certain Prohibited Transaction Restrictions
This document contains notices of pendency before the Department of Labor (the Department) of proposed exemptions from certain of the prohibited transaction restrictions of the Employee Retirement Income Security Act of 1974 (ERISA or the Act) and/or the Internal Revenue Code of 1986 (the Code). This notice includes the following proposed exemptions: D-11726, Rock Wool Manufacturing Company; L-11784, Eli Lilly and Company and Elco Insurance Company Limited; D-11798, Robert A. Handelman Roth IRA No. 2; and, D-11809 and L-11810, Roofers Local 195 Pension Fund and Roofers Local 195 Joint Apprenticeship Training Fund.
Filing Dates for the Illinois Special Elections in the 18th Congressional District
Illinois has scheduled special elections on June 8, 2015, and July 24, 2015, to fill the U.S. House of Representative seat in the 18th Congressional District vacated by Representative Aaron Schock. Committees required to file reports in connection with the Special Primary Election on June 8, 2015, shall file a 12-day Pre-Primary Report. Committees required to file reports in connection with both the Special Primary and the Special General Election on July 24, 2015, shall file a 12-day Pre-Primary Report, 12-day Pre-General Report and a Post-General Report.
Inland Waterways Users Board Meeting Notice
The Department of the Army is publishing this notice to announce the following Federal advisory committee meeting of the U.S. Army Corps of Engineers, Inland Waterways Users Board (Board). This meeting is open to the public. For additional information about the Board, please visit the committee's Web site at https:// www.iwr.usace.army.mil/Missions/Navigation/ InlandWaterwaysUsersBoard.aspx.
Agency Information Collection Activities; Submission to OMB for Review and Approval; Public Comment Request
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 renewal of the approved information collection assigned OMB control number 0990-0382, scheduled to expire on May 31, 2015. 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.
Consolidation of Officer in Charge, Marine Inspection for Outer Continental Shelf Activities; Eighth Coast Guard District; Technical, Organizational, and Conforming Amendments
The Coast Guard is issuing a final rule establishing a consolidated Officer in Charge, Marine Inspection (OCMI) for the purposes of inspecting mobile offshore drilling units, and fixed and floating facilities, engaged in OCS activities in the Eighth Coast Guard District. This final rule also addresses comments submitted in response to our notice and request for comments related to the consolidation of the OCMI, for OCS activities, and makes other non- substantive changes. This rule will have no substantive effect on the regulated public.
List of Environmentally Responsive Human Genes Selected for Use In Screening Large Numbers of Substances Using Toxicogenomic Approaches
The National Institute of Environmental Health Sciences (NIEHS)/National Toxicology Program (NTP) requests comments on a set of human genes that have been identified and prioritized as environmentally responsive genes. These genes will be used in toxicogenomics approaches to screen cells or tissues obtained from humans against large numbers of chemicals. The goal was to generate a set of approximately 1500 human genes to evaluate transcriptional changes in response to chemical exposures. Similar gene sets will be developed for screening cells or tissues from other species such as rats, mice, zebrafish, and Caenorhabditis elegans. The human gene set should provide maximal toxicogenomic information on effects from chemical exposures that reflect general cellular responses, independent of cell type or species, and gene expression changes that are specific by organ and/or cell type. Such a list of environmentally responsive genes may also be useful in biomarker development and basic research efforts. This list of genes, referred to as the ``S1500'' gene list, or gene set, is available for public comment.
Medicare and Medicaid Programs; Electronic Health Record Incentive Program-Modifications to Meaningful Use in 2015 Through 2017
This proposed rule would change the Medicare and Medicaid Electronic Health Record (EHR) Incentive Program EHR reporting period in 2015 to a 90-day period aligned with the calendar year, and also would align the EHR reporting period in 2016 with the calendar year. In addition, this proposed rule would modify the patient action measures in the Stage 2 objectives related to patient engagement. Finally, it would streamline the program by removing reporting requirements on measures which have become redundant, duplicative, or topped out through advancements in EHR function and provider performance for Stage 1 and Stage 2 of the Medicare and Medicaid EHR Incentive Programs.
Regulations Q, Y, and LL: Small Bank Holding Company Policy Statement; Capital Adequacy of Board-Regulated Institutions; Bank Holding Companies; Savings and Loan Holding Companies
The Board is adopting final amendments (Final Rule) to the Small Bank Holding Company Policy Statement (Regulation Y, Appendix C) (Policy Statement) that: raise from $500 million to $1 billion the asset threshold to qualify for the Policy Statement; and expand the scope of companies eligible under the Policy Statement to include savings and loan holding companies. The Board is also adopting final conforming revisions to Regulation Y and Regulation LL, the Board's regulations governing the operations and activities of bank holding companies and savings and loan holding companies, respectively, and Regulation Q, the Board's regulatory capital rules.
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