May 7, 2018 – Federal Register Recent Federal Regulation Documents
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340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation
The Health Resources and Services Administration (HRSA) administers section 340B of the Public Health Service Act, referred to as the ``340B Drug Pricing Program'' or the ``340B Program.'' HHS is soliciting comments on further delaying the effective date of the January 5, 2017, final rule that sets forth the calculation of the ceiling price and application of civil monetary penalties, and applies to all drug manufacturers that are required to make their drugs available to covered entities under the 340B Program. HHS proposes to further delay the effective date of the final rule published in the Federal Register from July 1, 2018, to July 1, 2019. HHS proposes this action to allow a more deliberate process of considering alternative and supplemental regulatory provisions and to allow for sufficient time for additional rulemaking.
Commercial Space Transportation Advisory Committee-Open Meeting
Pursuant to Section 10(a)(2) of the Federal Advisory Committee Act, notice is hereby given of a meeting of the Commercial Space Transportation Advisory Committee (COMSTAC).
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Small Health Care Provider Quality Improvement Program, OMB No. 0915-0387-Revision
In compliance with of the Paperwork Reduction Act of 1995, HRSA has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. HRSA published the 60-Day notice on January 8, 2018, FR Doc. 2018-00173. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.
Public Availability of FY 2016 Service Contracts Inventory Analysis, and Planned Analysis of FY 2017 Service Contracts Inventory
In accordance with Section 743 of Division C of the Consolidated Appropriations Act of 2010, the U.S. International Trade Commission is publishing this notice to advise the public of the availability of the FY 2016 Service Contracts Inventory Analysis, and Planned Analysis of FY 2017 Service Contracts Inventory. The FY 2016 inventory analysis provides information on specific service contract actions that were analyzed as part of the FY 2016 inventory. The 2016 inventory provides information on service contract actions over $25,000, which were made in FY 2016. The inventory information is organized by function to show how contracted resources are distributed throughout the agency. The inventory has been developed in accordance with guidance issued on November 5, 2010 and December 19, 2011, by the Office of Management and Budget's Office of Federal Procurement Policy (OFPP). OFPP's guidance is available at https:// www.whitehouse.gov/sites/whitehouse.gov/files/omb/procurement /memo/ service-contract-inventory-guidance.pdf. The FY 2017 inventory planned analysis provides information on which functional areas will be reviewed by the agency. The United States International Trade Commission has posted its FY 2016 inventory, FY 2017 planned analysis at the following link: https://www.usitc.gov/ procurement.htm.
Notice of Information Collection
The National Aeronautics and Space Administration, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public to take this opportunity to comment on the ``Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery'' for approval under the Paperwork Reduction Act (PRA). This collection was developed as part of a Federal Government-wide effort to streamline the process for seeking feedback from the public on service delivery. This notice announces our intent to submit this collection to OMB for approval and solicits comments on specific aspects for the proposed information collection,
Request for Comment: New Federal Real Property Profile Information for Communications Facility Installation
The General Services Administration is seeking input on the inclusion of communications facility installation information into the Federal Real Property Profile (FRPP).
Applications for New Awards; Assistance for Arts Education Program-Arts in Education National Program
The Department of Education (Department) is issuing a notice inviting applications for fiscal year (FY) 2018 for the Assistance for Arts Education Program (AAE)Arts in Education National Program (AENP) Grants, Catalog of Federal Domestic Assistance (CFDA) number 84.351F.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Rural Health Opioid Program Grant Performance Measures, OMB No. 0906-xxxx-NEW
In compliance with the Paperwork Reduction Act of 1995, HRSA has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. HRSA published the 60-day notice on December 15, 2017, FR Doc. 2017-27013. HRSA received one comment. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.
Safety Zone; Neches River, Beaumont, TX
The Coast Guard is establishing a temporary safety zone on navigable waters of the Neches River extending 500-feet on either side of the Kansas City Southern Railroad Bridge that crosses the Neches River in Beaumont, TX. The safety zone is necessary to protect the bridge as well as persons and property on or near the bridge from potential damage from passing vessels until missing and/or damaged fendering systems are repaired or replaced. Entry of certain vessels or persons into this zone is prohibited unless specifically authorized by the Captain of the Port Marine Safety Unit Port Arthur or a designated representative. We invite your comments on this rule.
Cook Inlet Regional Citizens' Advisory Council (CIRCAC) Recertification
This notice informs the public that the Coast Guard has completed its triennial recertification of the Cook Inlet Regional Citizens' Advisory Council (CIRCAC) as an alternative voluntary advisory group for Cook Inlet, Alaska. The certification allows the CIRCAC to monitor the activities of terminal facilities and crude oil tankers under an alternative composition other than prescribed Cook Inlet Program established by statute.
Safety Zone; Annual Events Requiring Safety Zones in the Captain of the Port Lake Michigan Zone-Marinette Logging and Heritage Fest
The Coast Guard will enforce the safety zone for the Marinette Logging and Heritage Festival Fireworks on the Menomonee River in Marinette, WI from 9 p.m. through 11 p.m. on July 14, 2018. This action is necessary and intended to ensure safety of life on navigable waters immediately prior to, during, and after the fireworks display. During the enforcement period, entry into, transiting, or anchoring within the safety zone is prohibited unless authorized by the Captain of the Port Lake Michigan or a designated representative.
Safety Zone; Ohio River, Metropolis, IL
The Coast Guard is establishing an emergency temporary safety zone for all navigable waters of the Ohio River extending from mile marker (MM) 939.8 to MM 943.0 near Metropolis, IL. This emergency safety zone is needed to protect life, vessels, and the marine environment due to the sinking of one barge in the navigable channel of the Ohio River near MM 940.8 and one barge near the left descending bank at MM 942.5. Entry of vessels or persons into this zone is prohibited unless specifically authorized by the Captain of the Port Sector Ohio Valley (COTP) or a designated representative.
Request for Data and Information on Technologies Used for Identifying Potential Developmental Toxicants
The National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) requests available data and information on approaches and/or technologies currently used for identifying potential developmental toxicants. Submitted information will be used to assess the state of the science and determine technical needs for non-animal test methods used to evaluate the potential of chemicals to induce adverse effects in offspring.
Government-Owned Inventions; Availability for Licensing
The invention listed below is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Government-Owned Inventions; Availability for Licensing
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S.
Prospective Grant of Exclusive Patent License: Antibodies Against TL1A, a TNF-Family Cytokine, for the Treatment and Diagnosis of Crohn's Disease, Ulcerative Colitis, Asthma, Psoriasis and Biliary Cirrhosis
The National Heart, Lung, and Blood Institute (``NHLBI''), an institute of the National Institutes of Health; an agency within the Department of Health and Human Services, is contemplating the grant of an exclusive patent license to commercialize the invention(s) embodied in the intellectual property estate stated in the Summary Information section of this notice to Precision IBD, Inc., located in San Diego, California, and incorporated under the laws of Delaware.
Approval and Promulgation of Air Quality Implementation Plans; Virginia; Regional Haze Plan and Visibility for the 2010 Sulfur Dioxide and 2012 Fine Particulate Standards
The Environmental Protection Agency (EPA) is issuing a supplement to its March 1, 2018 proposed approval of the Commonwealth of Virginia's (the Commonwealth or Virginia) request to change reliance on the Clean Air Interstate Rule (CAIR) to reliance on the Cross-State Air Pollution Rule (CSAPR) to address certain regional haze requirements and to convert the Agency's limited approval/limited disapproval of Virginia's regional haze SIP to a full approval. EPA's March 1, 2018 notice of proposed rulemaking (NPR) also proposed to approve the ``visibility element'' of Virginia's infrastructure SIP submittals for the 2010 sulfur dioxide (SO2) and 2012 fine particulate matter (PM2.5) national ambient air quality standards (NAAQS). This supplemental proposal clarifies the infrastructure elements the Agency is proposing to approve for the 2010 SO2 National Ambient Air Quality Standards (NAAQS) and proposes to remove EPA's June 7, 2012 federal implementation plan (FIP) for Virginia which replaced reliance on CAIR with reliance on CSAPR to address certain deficient regional haze requirements identified in the Commonwealth's regional haze state implementation plan (SIP). EPA is seeking comment only on the issues raised in this supplemental proposal and is not reopening for comment other issues raised in its prior proposal. This action is being taken under the Clean Air Act (CAA).
Dinotefuran; Receipt of Applications for Emergency Exemptions, Solicitation of Public Comment
EPA has received specific exemption requests from the Delaware Department of Agriculture (DDA), the Maryland Department of Agriculture (MDA), the Pennsylvania Department of Agriculture (PDA) and the Virginia Department of Agriculture and Consumer Services (VDACS) to use the insecticide dinotefuran (CAS No. 165252-70-0) to treat up to 58,118 acres of pome and stone fruits to control the brown marmorated stinkbug. The applicants propose uses which are supported by the Interregional Research Project Number 4 (IR-4) and have been requested in 5 or more previous years, and petitions for tolerances have not yet been submitted to the Agency. Therefore, EPA is soliciting public comment before making the decision whether to grant the exemptions.
Konjac Glucomannan; Exemption From the Requirement of a Tolerance
This regulation establishes an exemption from the requirement of a tolerance for residues of konjac glucomannan (CAS Reg. No. 37220- 17-0) when used as an inert ingredient on growing crops only at a concentration not to exceed 1% by weight in a pesticide formulation. Technology Services Group, on behalf of, Attune Agriculture, LLC, submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting establishment of an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of konjac glucomannan resulting from use in accordance with the terms of this exemption.
Receipt of a Pesticide Petition Filed for Residues of Diquat in or on Crop Group 6C, Dried Shelled Pea and Bean (Except Soybean); Correction
EPA issued a notice in the Federal Register of September 15, 2017, announcing the initial filing of a pesticide petition requesting the establishment or modification of regulations for residues of pesticide chemicals in or on various commodities.
Duddingtonia flagrans strain IAH 1297; Exemption from the Requirement of a Tolerance
This regulation establishes an exemption from the requirement of a tolerance for residues of Duddingtonia flagrans strain IAH 1297 in or on all food commodities when used in accordance with label directions and good agricultural practices. International Animal Health Products Pty. 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 Duddingtonia flagrans strain IAH 1297 under FFDCA.
Meeting of the United States Travel and Tourism Advisory Board
The United States Travel and Tourism Advisory Board (Board or TTAB) will hold a meeting on Thursday, May 24, 2018. The Board advises the Secretary of Commerce on matters relating to the U.S. travel and tourism industry. The purpose of the meeting is for Board members to discuss recommendations related to the importance of international travel and tourism to the United States. The final agenda will be posted on the Department of Commerce website for the Board at https:// trade.gov/ttab at least one week in advance of the meeting.
Debt Refinancing in 504 Loan Program
This rule finalizes the interim final rule (IFR) that was published on May 25, 2016, to implement the debt refinancing program reauthorized by Section 521 of Division E of the Consolidated Appropriations Act, 2016. In response to comments received on the IFR, this final rule makes some additional revisions to the program's regulations with respect to the definition of Qualified debt, the requirements related to Eligible Business Expenses, the refinancing of Projects involving single or limited use properties, and the disbursement period.
Food Additives Permitted in Feed and Drinking Water of Animals; Marine Microalgae
The Food and Drug Administration (FDA, we, or the Agency) is amending the regulations for food additives permitted in feed and drinking water of animals to provide for the safe use of dried marine microalgae as a source of docosahexaenoic acid (DHA) for use in complete, dry foods for adult dogs. This action is in response to a food additive petition filed by DSM Nutritional Products.
Polytetrafluoroethylene Resin From India: Preliminary Affirmative Determination of Sales at Less Than Fair Value, Postponement of Final Determination, and Extension of Provisional Measures
The Department of Commerce (Commerce) preliminarily determines that polytetrafluoroethylene (PTFE) resin from India is being, or is likely to be, sold in the United States at less than fair value (LTFV). The period of investigation (POI) is July 1, 2016, through June 30, 2017. Interested parties are invited to comment on this preliminary determination.
Polytetrafluoroethylene Resin From the People's Republic of China: Preliminary Affirmative Determination of Sales at Less Than Fair Value, Postponement of Final Determination, and Extension of Provisional Measures
The Department of Commerce (Commerce) preliminarily determines that polytetrafluoroethylene (PTFE) resin from the People's Republic of China (China) is being, or is likely to be, sold in the United States at less than fair value (LTFV). The period of investigation (POI) is January 1, 2017, through June 30, 2017. Interested parties are invited to comment on this preliminary determination.
Subsidy Programs Provided by Countries Exporting Softwood Lumber and Softwood Lumber Products to the United States; Request for Comment
The Department of Commerce (Commerce) seeks public comment on any subsidies, including stumpage subsidies, provided by certain countries exporting softwood lumber or softwood lumber products to the United States during the period July 1, 2017, through December 31, 2017.
Steel Wire Garment Hangers From the Socialist Republic of Vietnam: Rescission of Antidumping Duty Administrative Review; 2017-2018
The Department of Commerce (Commerce) is rescinding the administrative review of the antidumping duty (AD) order on steel wire garment hangers from the Socialist Republic of Vietnam (Vietnam) for the period of review (POR) February 1, 2017, through January 31, 2018.
Records Schedules; Availability and Request for Comments
The National Archives and Records Administration (NARA) publishes notice at least once monthly of certain Federal agency requests for records disposition authority (records schedules). Once approved by NARA, records schedules provide mandatory instructions on what happens to records when agencies no longer need them for current Government business. The records schedules authorize agencies to preserve records of continuing value in the National Archives of the United States and to destroy, after a specified period, records lacking administrative, legal, research, or other value. NARA publishes notice in the Federal Register for records schedules in which agencies propose to destroy records they no longer need to conduct agency business. NARA invites public comments on such records schedules.
Request for Applications for Appointment to the Citizens Coinage Advisory Committee
Pursuant to United States Code, the United States Mint is accepting applications for appointment to the Citizens Coinage Advisory Committee (CCAC) as a member representing the interests of the general public in the coinage of the United States.
Express Bridge Loan Pilot Program; Modification of Fee Policy
On October 16, 2017, the U.S. Small Business Administration (SBA) published a document announcing the Express Bridge Loan Pilot Program (Express Bridge Pilot). In that document, SBA provided an overview of the Express Bridge Pilot and modified an Agency regulation relating to loan underwriting for loans made under the Express Bridge Pilot. SBA continues to refine and improve the design of the Express Bridge Pilot and is issuing this document to revise the program requirements, including the modification of an Agency regulation relating to fees that can be collected from the Applicant or Borrower in connection with a loan made under the Express Bridge Pilot.
Revision of Agency Information Collection Activity Under OMB Review: Airport Security Part 1542
This notice announces that the Transportation Security Administration (TSA) has forwarded the Information Collection Request (ICR), Office of Management and Budget (OMB) control number 1652-0002, abstracted below to OMB for review and approval of a revision of the currently approved collection under the Paperwork Reduction Act (PRA). The ICR describes the nature of the information collection and its expected burden. The collection includes requirements for airport operators to submit certain information to TSA, as well as to maintain and update records to ensure compliance with security provisions.
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