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NMFS has evaluated three Resource Management Plans (RMPs) submitted to NMFS pursuant to the limitation on take prohibitions for actions conducted under Limit 6 of the 4(d) Rule for salmon and steelhead promulgated under the Endangered Species Act (ESA). The RMPs specify the propagation of three species of salmon in the Dungeness River watershed of Washington State. This document serves to notify the public that NMFS, by delegated authority from the Secretary of Commerce, has determined pursuant to Limit 6 of the ESA 4(d) Rule for salmon and steelhead that implementing and enforcing the plans will not appreciably reduce the likelihood of survival and recovery of the Puget Sound Chinook salmon and Puget Sound steelhead.
Early Clinical Trials With Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a document entitled ``Early Clinical Trials With Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information; Guidance for Industry.'' The guidance document provides investigational new drug application (IND) sponsors with recommendations regarding IND submissions for early clinical trials with live biotherapeutic products (LBPs) in the United States. The guidance announced in this notice updates the guidance of the same title dated February 2012 (February 2012 guidance) by addressing when the label on the commercially available products(s) would be considered adequate to satisfy the purpose of the chemistry, manufacturing, and control (CMC) information requirements.
Bioequivalence Recommendations for Paliperidone Palmitate; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA) is announcing the availability of a revised draft guidance for industry on generic paliperidone palmitate extended-release injectable suspension, entitled ``Draft Guidance on Paliperidone Palmitate.'' The recommendations provide specific guidance on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for paliperidone palmitate extended-release injectable suspension.
The Food and Drug Administration (FDA or Agency) is announcing a public workshop and an opportunity for public comment on Erythropoietic Protoporphyria (EPP). The public workshop is intended to discuss how best to facilitate and expedite the development of safe and effective drug therapies to treat signs and symptoms related to EPP. FDA will provide information for, and gain perspective from, patients and patient advocacy organizations, health care providers, academic experts, and industry on disease symptoms and its impact on daily life, experience with current treatment regimens for EPP, and various aspects of clinical development of products intended to treat EPP. The input from this public workshop will help in developing topics for further discussion.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Vulvovaginal Candidiasis: Developing Drugs for Treatment.'' The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment of uncomplicated vulvovaginal candidiasis (VVC).
Notice of Lodging of Proposed Consent Decree Under the Comprehensive Environmental Response, Compensation, and Liability Act
We (the U.S. Geological Survey) will ask the Office of Management and Budget (OMB) to approve the information collection (IC) described below. As required by the Paperwork Reduction Act (PRA) of 1995, and as part of our continuing efforts to reduce paperwork and respondent burden, we invite the general public and other Federal agencies to take this opportunity to comment on this IC. This collection is scheduled to expire on November 30, 2016.
The North Pacific Fishery Management Council's Stock Structure and Spatial Management public workshop will meet July 21, 2016.
Agency Information Collection Activities: Application for Waiver of Grounds of Inadmissibility, Form I-690; Extension, Without Change, of a Currently Approved Collection
The Department of Homeland Security (DHS), U.S. Citizenship and Immigration (USCIS) invites the general public and other Federal agencies to comment upon this proposed extension of a currently approved collection of information. In accordance with the Paperwork Reduction Act (PRA) of 1995, the information collection notice is published in the Federal Register to obtain comments regarding the nature of the information collection, the categories of respondents, the estimated burden (i.e. the time, effort, and resources used by the respondents to respond), the estimated cost to the respondent, and the actual information collection instruments.
The National Advisory Council on Innovation and Entrepreneurship (NACIE) will hold a teleconference meeting on Tuesday, July 12, 2016, 3:00-3:30 p.m. Eastern Standard Time (EST) and will be open to the public. During this time, members will discuss and vote on their recommendations to develop an Innovation Encyclopedia, conduct research and pilot two Entrepreneurship & Innovation Community Exchanges, and best practices to be passed to the next Council. Approved recommendations will be presented to the Secretary in August. The meeting will take place via teleconference.
Newvista Property Holdings, LLC-Adverse Abandonment of the Ironton Branch-In Utah County, Utah; Newvista Property Holdings, LLC-Petition For Declaratory Order
Agency Information Collection Activities: Privacy of Consumer Financial Information Recordkeeping and Disclosure Requirements Under Gramm-Leach-Bliley Act and Regulation P, Comment Request
NCUA, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to comment on the submission for reinstatement of a previously approved collection, as required by the Paperwork Reduction Act of 1995 (Pub. L. 104-13, 44 U.S.C. Chapter 35). NCUA is soliciting comment on the reinstatement of the information collection described below.
This notice provides information to clarify Move Update standards and to assist mailers in their compliance with those standards.
The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, 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. This notice invites comment on Aggregate Reports for Tuberculosis Program Evaluation. The goal of the study is to allow CDC to collect and monitor indicators for key program activities, such as finding tuberculosis infections in recent contacts of cases and in other persons likely to be infected and providing therapy for latent tuberculosis infection in an effort to eliminate Tuberculosis in the United States.
The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, 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. This notice invites comment on Development of CDC's Act Against AIDS Social Marketing Campaigns Targeting Consumers. CDC is requesting approval for revision to the previously approved project to continue testing HIV/AIDS prevention and treatment messages to be included in social marketing campaigns targeting consumers.
Submission for OMB Review; 30-Day Comment Request; Population Assessment of Tobacco and Health (PATH) Study-Fourth Wave of Data Collection
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 for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on April 15, 2016, pages 2229022291 and allowed 60-days for public comment. No public comments were 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. Direct Comments To OMB: 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: Office of Management and Budget, Office of Regulatory Affairs, OIRA_Submission@omb.eop.gov or by fax to (202) 395-6974, Attention: NIH Desk Officer. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30 days of the date of this publication.
Inflation Adjustment of the Ordinary Maximum and Aggravated Maximum Civil Monetary Penalties for a Violation of the Hazardous Material Transportation Laws or Regulations, Orders, Special Permits, and Approvals Issued Under Those Laws
To comply with the Federal Civil Penalties Inflation Adjustment Act of 1990, as amended by the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015, FRA is adjusting the minimum penalty, ordinary maximum penalty, and the aggravated maximum penalty that it will apply when assessing a civil monetary penalty for a knowing violation of the Federal hazardous material transportation laws or a regulation, special permit, order, or approval issued under those laws. The aggravated maximum penalty is available only for a violation that results in death, serious illness, or severe injury to any person or substantial destruction of property. In particular, FRA is increasing the minimum penalty for a training violation from $450 to $463; the ordinary maximum civil monetary penalty per violation from $75,000 to $77,114; and the aggravated maximum civil penalty from $175,000 to $179,933.
Implementation of the Federal Civil Penalties Inflation Adjustment Act Improvements Act for a Violation of a Federal Railroad Safety Law or Federal Railroad Administration Safety Regulation or Order
To comply with the Federal Civil Penalties Inflation Adjustment Act of 1990, as amended by the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015, FRA is adjusting the minimum, maximum, and aggravated maximum penalties that it will apply when assessing a civil penalty for a violation of a railroad safety statute, regulation, or order under its authority. In particular, FRA is increasing the minimum civil penalty per violation from $650 to $839, the ordinary maximum civil penalty per violation from $25,000 to $27,455, and the aggravated maximum civil penalty (i.e., the maximum civil penalty per violation where a grossly negligent violation or a pattern of repeated violations has created an imminent hazard of death or injury or has caused death or injury) from $105,000 to $109,819.
Reassignment of Post Office Box Section 98025 to Competitive Fee Group, and of Sections 87325 and 87326 to Market Dominant Fee Groups
The Postal Service hereby provides notice that Post Office[supreg] Box service for ZIP Code[supreg] 98025 is reassigned from its market dominant fee group to a competitive fee group, and Post Office Box services for ZIP Code 87325 and ZIP Code 87326 are reassigned from their competitive fee groups to market dominant fee groups.
The Corporation for National and Community Service (CNCS), as part of its continuing effort to reduce paperwork and respondent burden, conducts a pre-clearance consultation program to provide the general public and federal agencies with an opportunity to comment on proposed and/or continuing collections of information in accordance with the Paperwork Reduction Act of 1995 (PRA95) (44 U.S.C. Sec. 3506(c)(2)(A)). This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. Currently, CNCS is soliciting comments concerning application instructions designed to be used for grant competitions which CNCS sponsors when appropriations are available. Copies of the information collection request can be obtained by contacting the office listed in the ADDRESSES section of this Notice.
This interim final rule implements the provisions of the Federal Civil Penalties Inflation Adjustment Act of 1990, as amended by the Debt Collection Improvement Act of 1996 and the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015, with respect to the civil penalty provision of the Alcoholic Beverage Labeling Act of 1988 (ABLA). Specifically, this interim final rule increases the maximum civil monetary penalty for violations of the provisions of the ABLA from $10,000 to $19,787, in accordance with Federal law.
The Coast Guard will enforce five safety zones for annual firework displays in the Captain of the Port, Puget Sound Zone during the dates and times noted under SUPPLEMENTARY INFORMATION. This action is necessary to prevent injury and to protect life and property of the maritime public from the hazards associated with the firework displays. During the enforcement periods, entry into, transit through, mooring, or anchoring within these safety zones is prohibited unless authorized by the Captain of the Port, Puget Sound or their Designated Representative.
Notice is hereby given that a complaint was filed with the U.S. International Trade Commission on May 27, 2016, under section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337, on behalf of FUJIFILM Corporation of Tokyo, Japan and FUJIFILM Recording Media U.S.A., Inc. of Bedford, Massachusetts. Supplements to the complaint were filed on June 6, 8, and 10, 2016. 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 magnetic data storage tapes and cartridges containing the same by reason of infringement of U.S. Patent No. 6,641,891 (``the '891 patent''); U.S. Patent No. 6,703,106 (``the '106 patent''); U.S. Patent No. 6,703,101 (``the '101 patent''); U.S. Patent No. 6,767,612 (``the '612 patent''); U.S. Patent No. 8,236,434 (``the '434 patent''); and U.S. Patent No. 7,355,805 (``the '805 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 a limited exclusion order and cease and desist orders.
We are proposing to amend the regulations governing the importation of certain animals, meat, and other animal products by allowing, under certain conditions, the importation of bone-in ovine meat from Uruguay. Based on the evidence in a risk assessment that we have prepared, we believe that bone-in ovine meat can safely be imported from Uruguay provided certain conditions are met. This proposal would provide for the importation of bone-in ovine meat from Uruguay into the United States, while continuing to protect the United States against the introduction of foot-and-mouth disease.
Certain Inkjet Printers, Printheads, and Ink Cartridges, Components Thereof, and Products Containing Same; Institution of Investigation
Notice is hereby given that a complaint was filed with the U.S. International Trade Commission on May 27, 2016, under section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337, on behalf of HP Inc. of Palo Alto, California. 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 inkjet printers, printheads, and ink cartridges, components thereof, and products containing same by reason of infringement of certain claims of U.S. Patent No. 6,270,201 (``the '201 Patent''); U.S. Patent No. 6,491,377 (``the '377 Patent''); U.S. Patent No. 6,260,952 (``the '952 Patent''); U.S. Patent No. 7,004,564 (``the '564 Patent''); U.S. Patent No. 7,090,343 (``the '343 Patent''); and U.S. Patent No. 7,744,202 (``the '202 Patent''). The complaint further alleges that an industry in the United States exists as required by subsection (a)(2) of section 337. The complainant request that the Commission institute an investigation and, after the investigation, issue a general exclusion order, or in the alternative a limited exclusion order, and cease and desist orders.
The Federal Housing Finance Agency (FHFA) is adopting an interim final rule to implement the Program Fraud Civil Remedies Act of 1986 (31 U.S.C. 3801 et seq.) (PFCRA), by establishing administrative procedures for imposing civil penalties and assessments against persons who make false, fictitious, or fraudulent claims or written statements to FHFA in the context of its contracting or employment activities, where the amount of money or the value of property or services involved or requested from FHFA is $150,000 or less. FHFA previously issued a notice of proposed rulemaking to implement PFCRA. This rule is issued as an interim final rule rather than as a final rule because it increases the maximum penalty amount set forth in the proposed rule as required by the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (Adjustment Improvements Act), and that Act also requires that such ``catch up'' adjustments be published in the form of an interim final rule. If, prior to the effective date of the interim final rule, FHFA does not receive any comments from which FHFA concludes that the rule should be revised, this rule will become final without further action by FHFA.
The Federal Housing Finance Agency (FHFA) is issuing this interim final rule amending its Rules of Practice and Procedure and other agency regulations to adjust each civil money penalty within its jurisdiction to account for inflation, pursuant to the Federal Civil Penalties Inflation Adjustment Act of 1990, as amended by the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015. If, prior to the effective date of the interim final rule, FHFA does not receive any comments from which FHFA concludes that the rule should be revised, this rule will become final without further action by FHFA.
2-propenoic acid, 2-methyl-, 2-oxiranylmethyl ester, polymer With ethene, ethenyl acetate, ethenyltrimethoxysilane and sodium ethenesulfonate (1:1); Tolerance Exemption
This regulation establishes an exemption from the requirement of a tolerance for residues of 2-propenoic acid, 2-methyl-, 2- oxiranylmethyl ester, polymer with ethene, ethenyl acetate, ethenyltrimethoxysilane and sodium ethenesulfonate (1:1); when used as an inert ingredient in a pesticide chemical formulation. Celanese Ltd. submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of 2-propenoic acid, 2-methyl-, 2- oxiranylmethyl ester, polymer with ethene, ethenyl acetate, ethenyltrimethoxysilane and sodium ethenesulfonate (1:1) on food or feed commodities.
Certain Beverage Brewing Capsules, Components Thereof, and Products Containing the Same; Notice of Institution of Formal Enforcement Proceeding
Notice is hereby given that the U.S. International Trade Commission has instituted a formal enforcement proceeding relating to March 17, 2016 limited exclusion order and cease and desist order issued in the above-referenced investigation.
Certain Windshield Wipers and Components Thereof; Commission Determination To Grant the Joint Motion To Terminate the Investigation on the Basis of a Settlement Agreement; Termination of Investigation
Notice is hereby given that the U.S. International Trade Commission has determined to grant the joint motion to terminate the above-referenced investigation based on a settlement agreement.
Certain Laser-Driven Light Sources, Subsystems Containing Laser-Driven Light Sources, and Products Containing Same; Commission Determination Not To Review an Initial Determination Granting a Joint Motion To Terminate the Investigation Based on a Settlement Agreement
Notice is hereby given that the U.S. International Trade Commission has determined not to review an initial determination (``ID'') (Order No. 12) issued by the presiding administrative law judge (``ALJ'') granting a joint motion to terminate the investigation based on a settlement agreement.
The Environmental Protection Agency (EPA) is approving a State Implementation Plan (SIP) revision submitted by the New Jersey Department of Environmental Protection. This revision establishes an updated ten-year carbon monoxide (CO) limited maintenance plan for the New Jersey portion of the New York-Northern New Jersey-Long Island (NYNNJLI) CO area which includes the following areas: Hudson, Essex, Bergen, and Union Counties, and the municipalities of Clifton, Passaic and Paterson in Passaic County. New Jersey qualifies for a limited maintenance plan, rather than a full maintenance plan, because monitoring concentrations of CO are less than 85% of the standard. In a limited maintenance plan, future-year projection inventories and transportation conformity budgets are not required. In addition, EPA is also approving the 2007 Attainment/Base Year CO emissions inventory and the shutdown of 5 CO maintenance monitors in New Jersey. The New Jersey portion of the NYNNJLI CO area was redesignated to attainment of the CO National Ambient Air Quality Standard (NAAQS) on August 23, 2002 and a maintenance plan was also approved at that time. By this action, EPA is approving a second limited maintenance plan for this area because it provides for continued attainment of the CO NAAQS for an additional ten years. The intended effect of this rulemaking is to approve a SIP revision that will insure continued maintenance of the CO NAAQS.
The Coast Guard is establishing a safety zone on the navigable waters of the confluence of the James River and the Appomattox River in Hopewell, Virginia. This safety zone will restrict vessel movement within a 700-foot radius of the fireworks barge during the fireworks display for the City of Hopewell centennial celebration. This action is necessary to provide for the safety of life and property on the surrounding navigable waters during the fireworks display.
Oil and Gas and Sulphur Operations in the Outer Continental Shelf-Civil Penalties Inflation Adjustments
This rule adjusts the level of civil monetary penalties contained in the Bureau of Ocean Energy Management (BOEM) regulations pursuant to the Outer Continental Shelf Lands Act, the Oil Pollution Act of 1990, the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 and Office of Management and Budget guidance.
We, the U.S. Fish and Wildlife Service (Service), have issued the following permits to conduct certain activities with endangered species, marine mammals, or both. We issue these permits under the Endangered Species Act (ESA) and Marine Mammal Protection Act (MMPA).
We, the U.S. Fish and Wildlife Service, invite the public to comment on the following applications to conduct certain activities with endangered species, marine mammals, or both. With some exceptions, the Endangered Species Act (ESA) and Marine Mammal Protection Act (MMPA) prohibit activities with listed species unless Federal authorization is acquired that allows such activities.
The Employment and Training Administration (ETA) of the U.S. Department of Labor (the Department or DOL) issues this notice to announce its final decision to close the Ouachita Civilian Conservation Center (Ouachita) in Royal, Arkansas. The Office of Job Corps (OJC) in ETA published an updated methodology for selecting a Job Corps Center for closure and requested comments on the proposed decision to close Ouachita at 81 FR 12529 on March 9, 2016. A total of 292 public comments were received in response to the proposal to close Ouachita. After reviewing all comments, the Department has decided to close the Ouachita Job Corps Center.
Direct Investment Surveys: BE-13, Survey of New Foreign Direct Investment in the United States, and Changes to Private Fund Reporting on Direct Investment Surveys
This proposed rule would amend regulations of the Department of Commerce's Bureau of Economic Analysis (BEA) to set forth the reporting requirements for the BE-13, Survey of New Foreign Direct Investment in the United States. This proposed rule also provides information about, and an opportunity to comment on, plans to amend the reporting requirements for certain private funds on BEA's surveys of foreign direct investment in the United States, including the BE-605, Quarterly Survey of Foreign Direct Investment in the United States; the BE-15, Annual Survey of Foreign Direct Investment in the United States; and the BE-13, Survey of New Foreign Direct Investment in the United States. The BE-13 survey collects information on the acquisition or establishment of U.S. business enterprises by foreign investors, and information on expansions by existing U.S. affiliates of foreign companies. The data collected through the survey are used to measure the amount of new foreign direct investment in the United States and ensure complete coverage of BEA's other foreign direct investment statistics. BEA proposes several changes to the survey that will simplify reporting and provide more complete information for use in BEA's direct investment statistics. BEA also proposes changes in survey form design and accompanying instructions to improve the quality of the data collected and reduce respondent burden. This mandatory BE-13 survey is required from persons subject to the reporting requirements, whether or not they are contacted by BEA.
The Commission is noticing recent Postal Service filings 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.
Reactive Supply Compensation in Markets Operated by Regional Transmission Organizations and Independent System Operators; Supplemental Notice of Workshop