August 24, 2018 – Federal Register Recent Federal Regulation Documents
Results 51 - 100 of 138
Early Engagement Opportunity: Implementation of National Defense Authorization Act for Fiscal Year 2019
DoD announces an early engagement opportunity regarding implementation of the National Defense Authorization Act for Fiscal Year 2019 within the acquisition regulations.
Order of Succession for HUD Region I
In this notice, the Assistant Deputy Secretary for Field Policy and Management, Department of Housing and Urban Development, designates the Order of Succession for the Boston Regional Office and its Field Offices (Region I). This Order of Succession supersedes all previous Orders of Succession for HUD Region I.
Revision of the Land Management Plan for El Yunque National Forest
El Yunque National Forest, located in Puerto Rico, has prepared a Final Environmental Impact Statement (FEIS), a Revised Land Management Plan and a Draft Record of Decision (ROD). This notice is to inform the public that a 60-day period is being initiated where individuals or entities with specific concerns on El Yunque's Revised Land Management Plan and its associated FEIS may file an objection for a Forest Service review prior to the approval of the Revised Land Management Plan.
Tennessee Valley Authority, Browns Ferry Nuclear Plant Units 1, 2 and 3, Sequoyah Nuclear Plant, Units 1 and 2, Watts Bar Nuclear Plant, Units 1 and 2
The U.S. Nuclear Regulatory Commission (NRC) has granted the request of Tennessee Valley Authority (the licensee) to withdraw its application dated July 6, 2018, for proposed amendments to Renewed Facility Operating License Nos. DPR-33, DPR-52, DPR-68, DPR-77 and DPR- 79, and Facility Operating License Nos. NPF-90 and NPF-96. The proposed amendments would have revised the implementation date of Tennessee Valley Authority's emergency action level schemes based on the Nuclear Energy Institute (NEI) document NEI 99-01, Revision 6, ``Development of Emergency Action Levels for Non- Passive Reactors,'' from July 3, 2018, to November 3, 2018.
Notice of OFAC Sanctions Actions
The Department of the Treasury's Office of Foreign Assets Control (OFAC) is publishing the names of one or more persons and vessels that have been placed on OFAC's Specially Designated Nationals and Blocked Persons List based on OFAC's determination that one or more applicable legal criteria were satisfied. All property and interests in property subject to U.S. jurisdiction of these persons and these vessels are blocked, and U.S. persons are generally prohibited from engaging in transactions with them.
Schedules for Atlantic Shark Identification Workshops and Safe Handling, Release, and Identification Workshops
Free Atlantic Shark Identification Workshops and Safe Handling, Release, and Identification Workshops will be held in October, November, and December of 2018. Certain fishermen and shark dealers are required to attend a workshop to meet regulatory requirements and to maintain valid permits. Specifically, the Atlantic Shark Identification Workshop is mandatory for all federally permitted Atlantic shark dealers. The Safe Handling, Release, and Identification Workshop is mandatory for vessel owners and operators who use bottom longline, pelagic longline, or gillnet gear, and who have also been issued shark or swordfish limited access permits. Additional free workshops will be conducted during 2019 and will be announced in a future notice.
Fisheries of the Exclusive Economic Zone Off Alaska; Reallocation of Pollock in the Bering Sea Subarea
NMFS is reallocating projected unused amounts of Bering Sea subarea pollock from the incidental catch allowance to the directed fisheries. This action is necessary to allow the 2018 total allowable catch (TAC) of pollock to be harvested.
New Postal Products
The Commission is noticing a recent Postal Service filing for the Commission's consideration concerning negotiated service agreements. This notice informs the public of the filing, invites public comment, and takes other administrative steps.
Request for Nominations for the National Advisory Council on Nurse Education and Practice
HRSA is requesting nominations to fill vacancies on the National Advisory Council on Nurse Education and Practice (NACNEP). The NACNEP is authorized by Section 851 of the Public Health Service (PHS) Act, as amended. The Advisory Council is governed by the provisions of the Federal Advisory Committee Act (FACA), as amended, which sets forth standards for the formation and use of advisory committees, and applies to the extent that the provisions of FACA do not conflict with the requirements of PHS Act Section 851.
Request for Nominations for the Advisory Committee on Training in Primary Care Medicine and Dentistry
HRSA is requesting nominations to fill vacancies on the Advisory Committee on Training in Primary Care Medicine and Dentistry (ACTPCMD). The ACTPCMD is authorized by Section 749 of the Public Health Service (PHS) Act. The Advisory Committee is governed by provisions of the Federal Advisory Committee Act (FACA), as amended, which sets forth standards for the formation and use of advisory committees, and applies to the extent that the provisions of FACA do not conflict with the requirements of PHS Act Section 749.
Payment, Filing, and Service Procedures
The Surface Transportation Board (Board) proposes to modify its rules pertaining to certain payment, filing, and service procedures. Many of these rules are outdated and do not reflect current technology. As explained in this notice of proposed rulemaking (NPRM), the Board proposes updating its regulations relating to methods of payment, filing procedures, electronic service of Board decisions, and fees for copying, printing, and related services. The proposed updates are intended to promote increased use of electronic filing and payment systems and result in cost savings to both the Board and the public, while enhancing the accessibility of information relating to proceedings and functions of the Board.
Information Collection Request Submitted to OMB for Review and Approval; Comment Request; Asbestos-Containing Materials in Schools and Revised Asbestos Model Accreditation Plans (Renewal)
The Environmental Protection Agency (EPA) has submitted the following information collection request (ICR) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act (PRA): Asbestos-Containing Materials in Schools and Revised Asbestos Model Accreditation Plans (EPA ICR No. 1365.11, OMB Control No. 2070-0091). This is a request to renew the approval of an existing ICR, which is currently approved through August 31, 2018. EPA received six comments in response to the previously provided public review opportunity issued in the Federal Register of January 2, 2018, which have been addressed in the ICR that is being submitted to OMB, a copy of which is available in the docket. With this submission to OMB, EPA is providing an additional 30 days for public review and comment.
Information Collection Request Submitted to OMB for Review and Approval; Comment Request; Oil Pollution Act Facility Response Plan Requirements (Renewal)
The Environmental Protection Agency (EPA) has submitted an information collection request (ICR), Oil Pollution Act Facility Response Plans (EPA ICR No. 1630.13, OMB Control No. 2050-0135) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. This is a proposed extension of the ICR, which is currently approved through August 31, 2018. Public comments were previously requested via the Federal Register on March 21, 2018 during a 60-day comment period. This notice allows for an additional 30 days for public comments. A fuller description of the ICR is given below, including its estimated burden and cost to the public. An agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.
Hematologic Malignancy and Oncologic Disease: Considerations for Use of Placebos and Blinding in Randomized Controlled Clinical Trials for Drug Product Development; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Hematologic Malignancy and Oncologic Disease: Considerations for Use of Placebos and Blinding in Randomized Controlled Clinical Trials for Drug Product Development.'' This draft guidance provides recommendations to industry regarding the use of placebos and blinding in randomized controlled clinical trials in development programs for drug or biological products for the treatment of hematologic malignancies and oncologic diseases regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER).
Notice of OFAC Sanctions Actions
The Department of the Treasury's Office of Foreign Assets Control (OFAC) is publishing the names of one or more persons that have been placed on OFAC's Specially Designated Nationals and Blocked Persons List based on OFAC's determination that one or more applicable legal criteria were satisfied. All property and interests in property subject to U.S. jurisdiction of these persons are blocked, and U.S. persons are generally prohibited from engaging in transactions with them.
Minority Depository Institutions Advisory Committee
The Office of the Comptroller of the Currency (OCC) announces a meeting of the Minority Depository Institutions Advisory Committee (MDIAC).
Proposed Information Collection Activity
The Office of Planning, Research, and Evaluation (OPRE), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is proposing to collect data for a new round of the Head Start Family and Child Experiences Survey (FACES).
Agency Information Collection Activities; Submission for OMB Review; Comment Request; Comprehensive Iran Sanctions, Accountability, and Divestment Act of 2010 (“CISADA”) Reporting Requirements
The Department of the Treasury will submit the following information collection requests to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995, on or after the date of publication of this notice. The public is invited to submit comments on these requests.
Agency Information Collection Activities Under OMB Review
In compliance with the Paperwork Reduction Act of 1995 (``PRA''), this notice announces that the Information Collection Request (``ICR'') abstracted below has been forwarded to the Office of Management and Budget (``OMB'') for review and comment. The ICR describes the nature of the information collection and its expected costs and burden.
Notice of Issuance of Program Comment To Exempt Consideration of Effects to Rail Properties Within Rail Rights-of-Way
The Advisory Council on Historic Preservation (``ACHP'') issued a Program Comment to exempt consideration of effects to rail properties within rail rights-of-way at the request of the U.S. Department of Transportation to accelerate the review of these undertakings under Section 106 of the National Historic Preservation Act and to meet the requirement of Section 11504 of the Fixing America's Surface Transportation Act. The Program Comment can be used by any federal agency with responsibility to consider the effects of undertakings within rail rights-of-way. Federal agencies using the Program Comment may fulfill their Section 106 responsibilities for the relevant undertakings by implementing the terms of this comment, which include identifying those activities that meet the conditions in Appendix A and opting into the process to identify excluded historic rail properties and seek further streamlining of the review process under the property-based approach.
Traffic Records Program Assessment Advisory; Notice of Availability
States need timely, accurate, complete, accessible, and uniform traffic records to identify and prioritize traffic safety issues and to choose appropriate safety countermeasures and evaluate their effectiveness. Traffic records program assessments provide States with the information needed to plan traffic records improvement projects. The National Highway Traffic Safety Administration (NHTSA) announces the availability of a revised Traffic Records Program Assessment Advisory following review of comments received from States, associations, non-profit organizations, and individuals.
Hispanic Council on Federal Employment
The Hispanic Council on Federal Employment (Council) meeting will be held on at the following time and location shown below. The Council is an advisory committee composed of representatives from Hispanic organizations and senior Government officials. Along with its other responsibilities, the Council shall advise the Director of the U.S. Office of Personnel Management on matters involving the recruitment, hiring, and advancement of Hispanics in the Federal workforce. The Council is chaired by the Director of the U.S. Office of Personnel Management.
Notice of Intent To Seek Approval To Collect Information
In accordance with the Paperwork Reduction Act of 1995 and Office of Management and Budget regulations, this notice announces the request of the Agricultural Research Service, permission to collect information from North Dakota landowners in nine counties, to gain their perspective on their grasslands in the Northern Great Plains. A mail survey composed of 42 questions will be mailed to landowners. Topics for which information will be collected from respondents include farm/ranch characteristics, land management style, land use practices, opinions about new grass species, opinions about Kentucky bluegrass and what producers are doing about it, Kentucky bluegrass management, and personal characteristics.
Notice of Intent To Request Revision and Extension of a Currently Approved Information Collection
In accordance with the Paperwork Reduction Act of 1995, this notice announces the intent of the National Agricultural Statistics Service (NASS) to request revision and extension of a currently approved information collection to comply with a mandate in the 2014 Farm Bill. (. . . the Secretary of Agriculture should recognize the threat feral swine pose to the domestic swine population and the entire agriculture industry . . .).
Agency Information Collection Activities; Proposed eCollection eComments Requested; New Collection
The Department of Justice, Justice Management Division, Security and Emergency Planning Staff (SEPS), will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995.
Designating Additions to the Current List of Tropical Diseases in the Federal Food, Drug, and Cosmetic Act
The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes the Food and Drug Administration (FDA or Agency) to award priority review vouchers (PRVs) to tropical disease product applicants when the applications meet certain criteria. The FD&C Act lists the diseases that are considered tropical diseases for purposes of obtaining PRVs and provides for Agency expansion of that list to include other diseases that satisfy the definition of ``tropical diseases'' as set forth in the FD&C Act. The Agency has determined that chikungunya virus disease, Lassa fever, rabies, and cryptococcal meningitis satisfy this definition and is therefore adding them to the list of designated tropical diseases whose product applications may result in the award of PRVs. Sponsors submitting certain drug or biological product applications for the prevention or treatment of chikungunya virus disease, Lassa fever, rabies, and cryptococcal meningitis may be eligible to receive a PRV if such applications are approved by FDA.
Notice of Decision Not To Designate Pneumocystis Pneumonia as a Tropical Disease
The Food and Drug Administration (FDA or Agency), in response to suggestions submitted to Docket No. FDA-2008-N-0567, has analyzed whether Pneumocystis pneumonia (PCP) meets the statutory criteria for designation as a tropical disease for the purposes of obtaining a priority review voucher (PRV) under the Federal Food, Drug, and Cosmetic Act (FD&C Act), namely whether it primarily affects poor and marginalized populations and whether there is ``no significant market'' for drugs that prevent or treat PCP in developed countries. The Agency has determined that PCP does not meet the statutory criteria for designation as a tropical disease and declines to designate it as such.
Organization; Definitions; Eligibility Criteria for Outside Directors
The Farm Credit Administration (FCA, we, or our) is proposing to amend its regulations affecting the governance of Farm Credit System (System) institutions. The proposed rule would modify the existing outside director eligibility criteria by expanding the list of persons who would be excluded from nomination for an outside director's seat to ensure the independence of outside directors.
Determination That PLASMA-LYTE M AND DEXTROSE 5% and PLASMA LYTE 148 AND DEXTROSE 5% Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA or Agency) has determined that PLASMA-LYTE M AND DEXTROSE 5% (calcium chloride, 37 milligrams (mg)/100 milliliters (mL); dextrose, 5 grams (g)/100 mL; magnesium chloride, 30 mg/100 mL; potassium chloride, 119 mg/100 mL; sodium acetate, 161 mg/100 mL; sodium chloride, 94 mg/100 mL; sodium lactate, 138 mg/100 mL) and PLASMA LYTE 148 AND DEXTROSE 5% (dextrose, 5 g/100 mL; magnesium chloride, 30 mg/100 mL; potassium chloride, 37 mg/100 mL; sodium acetate, 368 mg/100 mL; sodium chloride, 526 mg/100 mL; sodium gluconate, 502 mg/100 mL) were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to these products as long as they meet relevant legal and regulatory requirements.
Agency Information Collection Activities; Proposed Collection; Comment Request; Prescription Drug User Fee Cover Sheet; Form FDA 3397
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. 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 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 the Prescription Drug User Fee Cover Sheet, Form FDA 3397, that must be submitted along with certain drug and biological product applications.
Site Visit Training Program for Office of Pharmaceutical Quality Staff; Information Available to Industry
The Center for Drug Evaluation and Research (CDER) in the Food and Drug Administration (FDA) is announcing the Fiscal Year 2019 CDER Office of Pharmaceutical Quality (OPQ) Staff Experiential Learning Site Visit Program. The purpose of this document is to invite pharmaceutical companies interested in participating in this program to submit a site visit proposal to CDER's OPQ.
Request for Comments and Notice of Public Hearing Concerning China's Compliance With WTO Commitments
The interagency Trade Policy Staff Committee (TPSC) invites interested persons to submit written comments and participate in a public hearing to assist the Office of the United States Trade Representative (USTR) in the preparation of its annual report to the Congress on China's compliance with the commitments made in connection with its accession to the World Trade Organization (WTO).
Proposed Information Collection; Comment Request; U.S. Fishermen Fishing in Russian Waters
The Department of Commerce, 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 proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995.
Certain Digital Cameras, Software, and Components Thereof; Notice of Request for Statements on the Public Interest
Notice is hereby given that the presiding administrative law judge has issued a Final Initial Determination and Recommended Determination on Remedy and Bonding in the above-captioned investigation. The Commission is soliciting comments on public interest issues raised by the recommended relief, specifically a limited exclusion order and cease and desist orders directed to each of the remaining named respondents: Nikon Corporation of Tokyo, Japan; Sendai Nikon Corporation of Natori, Japan; Nikon Inc. of Melville, New York; Nikon (Thailand) Co., Ltd. of Ayutthaya, Thailand; and Nikon Imaging (China) Co., Ltd. of Jiangsu, China. This notice is soliciting public interest comments from the public only. Parties are to file public interest submissions pursuant to Commission rules.
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