Results 1 - 50 of 406,053
Reader Aids
Document Number: FR-2018-02-16-ReaderAids
Type: Reader Aids
Date: 2018-02-16
Sunshine Act Meetings; National Science Board
Document Number: 2018-03316
Type: Notice
Date: 2018-02-16
Agency: National Science Foundation, Agencies and Commissions
Agency Information Collection Activities; Submission for OMB Review; Comment Request; Extension
Document Number: 2018-03289
Type: Notice
Date: 2018-02-16
Agency: Federal Trade Commission, Agencies and Commissions
The information collection requirements described below will be submitted to the Office of Management and Budget (``OMB'') for review, as required by the Paperwork Reduction Act (``PRA''). The FTC intends to ask OMB to extend for an additional three years the current PRA clearance for the FTC's enforcement of the information collection requirements in its Fair Packaging and Labeling Act regulations (``FPLA Rules''). That clearance expires on April 30, 2018.
Notice of Public Meeting of the Ohio Advisory Committee to the U.S. Commission on Civil Rights
Document Number: 2018-03285
Type: Notice
Date: 2018-02-16
Agency: Commission on Civil Rights
Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission) and the Federal Advisory Committee Act that the Ohio Advisory Committee (Committee) will hold a meeting via web conference on Friday March 2, 2018, from 11:30am-1:00 p.m. EST for the purpose of hearing public testimony on voting rights in the state.
Notice of Public Meetings of the Kansas Advisory Committee.
Document Number: 2018-03284
Type: Notice
Date: 2018-02-16
Agency: Commission on Civil Rights
Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission) and the Federal Advisory Committee Act that the Kansas Advisory Committee (Committee) will hold a meeting on Monday, March 5, 2018 from 12-1:30 pm Central time. The Committee will hear testimony from policy experts in the state as part of their current study on civil rights and school funding.
Notice of Public Meetings of the Arkansas Advisory Committee to the U.S. Commission on Civil Rights
Document Number: 2018-03283
Type: Notice
Date: 2018-02-16
Agency: Commission on Civil Rights
Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission) and the Federal Advisory Committee Act that the Arkansas Advisory Committee (Committee) will hold a meeting on Friday, March 9, 2018 at 12 p.m. Central time. The Committee will discuss approval of a project proposal to study civil rights and criminal justice in the state.
Procurement List; Additions
Document Number: 2018-03281
Type: Notice
Date: 2018-02-16
Agency: Committee for Purchase From People Who Are Blind or Severely Disabled, Agencies and Commissions
This action adds products to the Procurement List that will be furnished by nonprofit agencies employing persons who are blind or have other severe disabilities.
Docket No. BOEM-2017-0078]
Document Number: 2018-03280
Type: Notice
Date: 2018-02-16
Agency: Department of the Interior, Bureau of Ocean Energy Management
The Bureau of Ocean Energy Management (BOEM) is announcing the availability of a Record of Decision for proposed Gulf of Mexico (GOM) region-wide oil and gas Lease Sale 250. This Record of Decision identifies BOEM's selected alternative for proposed Lease Sale 250, which is analyzed in the Gulf of Mexico Outer Continental Shelf Lease Sale: Final Supplemental Environmental Impact Statement 2018 (2018 GOM Supplemental EIS).
Gulf of Mexico Outer Continental Shelf Oil and Gas Lease Sale 250; MMAA104000
Document Number: 2018-03278
Type: Notice
Date: 2018-02-16
Agency: Department of the Interior, Bureau of Ocean Energy Management
On Wednesday, March 21, 2018, the Bureau of Ocean Energy Management (BOEM) will open and publicly announce bids received for blocks offered in the Gulf of Mexico (GOM) Outer Continental Shelf (OCS) Region-wide Oil and Gas Lease Sale 250 (GOM Region-wide Sale 250), in accordance with the provisions of the Outer Continental Shelf Lands Act (OCSLA), as amended, and the implementing regulations issued pursuant thereto. The GOM Region-wide Sale 250 Final Notice of Sale (NOS) package contains information essential to potential bidders.
Pendimethalin; Pesticide Tolerances
Document Number: 2018-03277
Type: Rule
Date: 2018-02-16
Agency: Environmental Protection Agency
This regulation amends the tolerances for residues of pendimethalin in or on alfalfa, forage and alfalfa, hay. BASF Corporation requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
Privacy Act of 1974; System of Records
Document Number: 2018-03276
Type: Notice
Date: 2018-02-16
Agency: Department of Education
In accordance with the Privacy Act of 1974, as amended (Privacy Act), the Department of Education (Department) modifies in its inventory of system of records notices subject to the Privacy Act the system of records entitled ``Departmental Parking Control Policy'' (18- 05-01). The Departmental Parking Control Policy contains individually identifying information provided by individuals who wish to use parking spaces on Department-managed and Department-controlled property and on property assigned to the Department by the General Services Administration or any other Federal agency.
National Oil and Hazardous Substances Pollution Contingency Plan; National Priorities List: Deletion of the Hatheway & Patterson Superfund Site
Document Number: 2018-03275
Type: Rule
Date: 2018-02-16
Agency: Environmental Protection Agency
The Environmental Protection Agency (EPA) Region 1 announces the deletion of the Hatheway & Patterson Superfund Site (Site) located in Mansfield and Foxborough, Massachusetts, from the National Priorities List (NPL). The NPL, promulgated pursuant to section 105 of the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) of 1980, as amended, is an appendix of the National Oil and Hazardous Substances Pollution Contingency Plan (NCP). The EPA and the Commonwealth of Massachusetts, through the Massachusetts Department of Environmental Protection (MassDEP), have determined that all appropriate response actions under CERCLA, other than operation and maintenance, monitoring, and five-year reviews, have been completed. However, this deletion does not preclude future actions under Superfund.
2017 Quarterly Listings; Safety Zones, Security Zones, Special Local Regulations, Drawbridge Operation Regulations and Regulated Navigation Areas
Document Number: 2018-03273
Type: Rule
Date: 2018-02-16
Agency: Coast Guard, Department of Homeland Security
This document provides notification of substantive rules issued by the Coast Guard that were made temporarily effective but expired before they could be published in the Federal Register. This document lists temporary safety zones, security zones, special local regulations, drawbridge operation regulations and regulated navigation areas, all of limited duration and for which timely publication in the Federal Register was not possible.
Procurement List; Addition
Document Number: 2018-03272
Type: Notice
Date: 2018-02-16
Agency: Committee for Purchase From People Who Are Blind or Severely Disabled, Agencies and Commissions
This action adds a service to the Procurement List that will be provided by a nonprofit agency employing persons who are blind or have other severe disabilities.
Air Plan Approval; Douglas, Arizona; Second 10-Year Sulfur Dioxide Maintenance Plan
Document Number: 2018-03270
Type: Proposed Rule
Date: 2018-02-16
Agency: Environmental Protection Agency
The Environmental Protection Agency (EPA) is proposing to approve, as part of the State Implementation Plan (SIP) for the State of Arizona, the second 10-year maintenance plan for the Douglas maintenance area for the 1971 National Ambient Air Quality Standards (NAAQS or ``standards'') for sulfur dioxide (SO2).
Approval and Promulgation of State Implementation Plans; Alaska; Regional Haze Progress Report
Document Number: 2018-03269
Type: Proposed Rule
Date: 2018-02-16
Agency: Environmental Protection Agency
The Environmental Protection Agency (EPA) is proposing to approve a revision to the Alaska Regional Haze State Implementation Plan (SIP), submitted by the State of Alaska on March 10, 2016. Alaska submitted its Regional Haze Progress Report (``progress report'' or ``report'') and a negative declaration stating that further revision of the existing regional haze SIP is not needed at this time. Alaska submitted both the progress report and the negative declaration in the form of implementation plan revisions as required by federal regulations. The progress report addresses the federal Regional Haze Rule (RHR) requirements under the Clean Air Act (CAA) to submit a report describing progress in achieving reasonable progress goals (RPGs) established for regional haze and a determination of the adequacy of the state's existing plan addressing regional haze. We are also proposing to approve minor updates to the Enhanced Smoke Management Plan, Long-Term Strategy, and Commitment to Future 308 Plan Revision sections of the regional haze SIP, submitted concurrently with the progress report.
Special Local Regulation; Pamlico River, Washington, NC
Document Number: 2018-03268
Type: Rule
Date: 2018-02-16
Agency: Coast Guard, Department of Homeland Security
The Coast Guard is establishing a special local regulation on the navigable waters of the Pamlico River near Washington, North Carolina. This special local regulation is intended to restrict vessel traffic on the Pamlico River during a high-speed boat race. This action is intended to restrict vessel traffic movement in the regulated area to protect participants, spectators, and property from the hazards posed by high-speed boat races. Entry of vessels or persons into this special local regulation is prohibited unless specifically authorized by the Captain of the Port (COTP) North Carolina or a designated representative.
Safety Zone; Cape Fear River, Wilmington, NC
Document Number: 2018-03267
Type: Proposed Rule
Date: 2018-02-16
Agency: Coast Guard, Department of Homeland Security
The Coast Guard proposes to establish a temporary safety zone on the navigable waters of the Cape Fear River in New Hanover County, North Carolina. This temporary safety zone is intended to restrict vessel traffic on the Cape Fear River while a vessel prepares for and actively off-loads two new Post-Panamax gantry cranes to the North Carolina State Port Authority in Wilmington, North Carolina. This action is intended to restrict vessel traffic on the Cape Fear River to protect mariners and vessels from the hazards associated with off- loading the two gantry cranes. Entry of vessels or persons into this safety zone is prohibited unless specifically authorized by the Captain of the Port (COTP) North Carolina or a designated representative. This proposed rule is a follow-up action to a proposed rule that can be found in docket number USCG-2017-0965. We invite your comments on this proposed rulemaking.
Fisheries of the Exclusive Economic Zone Off Alaska; Pacific Cod by Vessels Using Pot Gear in the Central Regulatory Area of the Gulf of Alaska
Document Number: 2018-03266
Type: Rule
Date: 2018-02-16
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
NMFS is prohibiting directed fishing for Pacific cod by vessels using pot gear in the Central Regulatory Area of the Gulf of Alaska (GOA). This action is necessary to prevent exceeding the A season allowance of the 2018 Pacific cod total allowable catch apportioned to vessels using pot gear in the Central Regulatory Area of the GOA.
Voluntary Service National Advisory Committee, Notice of Meeting
Document Number: 2018-03265
Type: Notice
Date: 2018-02-16
Agency: Department of Veterans Affairs
Advisory Committee on Reactor Safeguards; Notice of Meeting
Document Number: 2018-03264
Type: Notice
Date: 2018-02-16
Agency: Nuclear Regulatory Commission, Agencies and Commissions
Change in Bank Control Notices; Acquisitions of Shares of a Bank or Bank Holding Company
Document Number: 2018-03262
Type: Notice
Date: 2018-02-16
Agency: Federal Reserve System, Agencies and Commissions
Request for Information on Improving the Military Selective Service Process and Increasing Participation in Military, National, and Public Service
Document Number: 2018-03261
Type: Notice
Date: 2018-02-16
The National Commission on Military, National, and Public Service (the ``Commission'') was created by Congress in the National Defense Authorization Act of Fiscal Year 2017 to ``conduct a review of the military selective service process (commonly referred to as `the draft') '' and to consider methods to increase participation in military, national, and public service in order to address national security and other public service needs of the Nation. In connection with this effort, Congress has directed the Commission to seek written comments from the general public and interested parties on matters of the Commission's review. The Commission seeks to learn more about the general public's views on these topics, including what has encouraged or discouraged them to perform voluntary or paid services for their communities at all levels.
Fermi Research Alliance, et al.; Notice of Decision on Application for Duty-Free Entry of Scientific Instruments
Document Number: 2018-03260
Type: Notice
Date: 2018-02-16
Agency: Department of Commerce, International Trade Administration
Codex Alimentarius Commission: Meeting of the Codex Committee on Residues of Veterinary Drugs in Food
Document Number: 2018-03257
Type: Notice
Date: 2018-02-16
Agency: Department of Agriculture, Food Safety and Inspection Service
The Office of the Deputy Under Secretary for Food Safety, U.S. Department of Agriculture (USDA), and the Food and Drug Administration (FDA), are sponsoring a public meeting on April 4, 2018. The objective of the public meeting is to provide information and receive public comments on agenda items and draft United States (U.S.) positions to be discussed at the 24th Session of the Codex Alimentarius Commission's (Codex's) Committee on Residues of Veterinary Drugs in Foods (CCRVDF), taking place in Chicago, Illinois, April 23-27, 2018. The Deputy Under Secretary for Food Safety and the FDA recognize the importance of providing interested parties the opportunity to obtain background information on the 24th Session of the CCRVDF and to address items on the agenda.
Submission for OMB Review; Comment Request
Document Number: 2018-03256
Type: Notice
Date: 2018-02-16
Agency: Department of Agriculture
Agency Information Collection Activities; Nonferrous Metals Surveys
Document Number: 2018-03255
Type: Notice
Date: 2018-02-16
Agency: Geological Survey, Department of the Interior
In accordance with the Paperwork Reduction Act of 1995, the U.S. Geological Survey (USGS) is proposing to renew an information collection.
Privacy Act of 1974; System of Records
Document Number: 2018-03254
Type: Notice
Date: 2018-02-16
Agency: Department of Education
In accordance with the Privacy Act of 1974, as amended (Privacy Act) (5 U.S.C. 552a), the Department of Education (Department or ED) publishes this notice of a modified system of records entitled ``Student Loan Repayment Benefits Case Files'' (18-05-15). The system contains records related to employees and job candidates who are being considered for student loan repayment benefits under the Department's Human Capital Policy 537-1 entitled ``Student Loan Repayment Program,'' as well as individuals who have been approved for and are receiving such benefits. The information maintained in the system of records entitled ``Student Loan Repayment Benefits Case Files'' consists of one or more of the following: Request letters from selecting officials or supervisors with supporting documentation; employees' and job candidates' names, home and work addresses, Social Security numbers, student loan account numbers, loan balances, repayment schedules, repayment histories, and repayment status; the loan holders' names, addresses, and telephone numbers; and a signed written service agreement in which an employee or job candidate agrees to complete a specified period of employment with ED. The information that will be maintained in the modified system of records will be collected through various sources, including directly from the individual to whom the information applies, officials of the Department, and official Department documents. The Department published a notice of a modified system of records in the Federal Register on December 23, 2016 (81 FR 94353). The Department is hereby modifying that notice, and is republishing it in full.
Agency Information Collection Activities: Information Collection Renewal; Submission for OMB Review; Investment Securities
Document Number: 2018-03253
Type: Notice
Date: 2018-02-16
Agency: Office of the Comptroller of the Currency, Department of Treasury, Department of the Treasury
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 respondents are 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 the renewal of its information collection titled, ``Investment Securities.'' The OCC also is giving notice that it has sent the collection to OMB for review.
Air Plan Approval; Connecticut; Nonattainment New Source Review Permit Requirements for the 2008 8-Hour Ozone Standard
Document Number: 2018-03252
Type: Rule
Date: 2018-02-16
Agency: Environmental Protection Agency
The Environmental Protection Agency (EPA) is taking final action to approve the state implementation plan (SIP) revision submitted on March 9, 2017 by the Connecticut Department of Energy and Environmental Protection (CT DEEP) addressing the nonattainment new source review (NNSR) requirements for the 2008 8-hour ozone National Ambient Air Quality Standard (NAAQS). The SIP revision addresses both of Connecticut's ozone nonattainment areas for the 2008 ozone NAAQS; the Greater Connecticut area and the Connecticut portion of the New York-N. New Jersey-Long Island, NY-NJ-CT area. The Connecticut portion of the New York-N. New Jersey-Long Island, NY-NJ-CT ozone nonattainment area consists of Fairfield, New Haven, and Middlesex counties. The Greater Connecticut nonattainment area includes the rest of the State. This action is being taken pursuant to the Clean Air Act (CAA or Act) and its implementing regulations.
Air Plan Approval; New Hampshire; Rules for Open Burning and Incinerators
Document Number: 2018-03251
Type: Rule
Date: 2018-02-16
Agency: Environmental Protection Agency
The Environmental Protection Agency (EPA) is approving State Implementation Plan (SIP) revisions submitted by the State of New Hampshire on August 9, 2011 and July 23, 2013. These SIP revisions establish rules for open burning and establish emission standards and operating practices for incinerators and wood waste burners that are not regulated pursuant to Federal incinerator standards. We are also approving revisions to the definitions of ``Incinerator'' and ``Wood Waste Burner,'' submitted by the State on July 23, 2013 and October 26, 2016, respectively. This action is being taken in accordance with the Clean Air Act (CAA).
New Postal Products
Document Number: 2018-03250
Type: Notice
Date: 2018-02-16
Agency: Postal Regulatory Commission, Agencies and Commissions
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.
Pine Creek Mine, LLC; Notice of Availability of Environmental Assessment
Document Number: 2018-03248
Type: Notice
Date: 2018-02-16
Agency: Department of Energy, Federal Energy Regulatory Commission
Determination of Regulatory Review Period for Purposes of Patent Extension; MOVANTIK
Document Number: 2018-03245
Type: Notice
Date: 2018-02-16
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for MOVANTIK and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications 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.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2018-03243
Type: Notice
Date: 2018-02-16
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
Through this Request for Information (RFI), the Agency for Healthcare Research and Quality (AHRQ) is seeking information from the public, hospitals and other health care organizations, clinicians, quality improvement experts, researchers, and quality measure developers about current use of the AHRQ Quality Indicators (AHRQ QIs) for quality improvement efforts. AHRQ recognizes that the AHRQ QIs have been adopted for other uses, but for the purpose of this RFI, the Agency is specifically seeking information about quality improvement initiatives such as those that seek to: Improve clinical practice (e.g., adherence to guidelines, coordination of care); improve patient safety or reduce harm; address disparities in health or care; improve prevention practices; and collaborate with community groups to improve health or care. AHRQ is also seeking information about the ways in which the Agency can increase use of the AHRQ QI measures for quality improvement, for example by refining measures, summarizing best practices, creating training materials, developing standardized metrics, and/or convening learning networks. To learn more about the AHRQ QIs, visit https://www.qualityindicators.ahrq.gov/.
Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Work Colleges Expenditure Report
Document Number: 2018-03242
Type: Notice
Date: 2018-02-16
Agency: Department of Education
In accordance with the Paperwork Reduction Act of 1995, ED is proposing a new information collection.
Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Work Colleges Application and Agreement
Document Number: 2018-03241
Type: Notice
Date: 2018-02-16
Agency: Department of Education
In accordance with the Paperwork Reduction Act of 1995, ED is proposing a new information collection.
Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Teacher Cancellation Low Income Directory
Document Number: 2018-03240
Type: Notice
Date: 2018-02-16
Agency: Department of Education
In accordance with the Paperwork Reduction Act of 1995, ED is proposing an extension of an existing information collection.
Safety Zone; Pensacola Bay, Pensacola, FL
Document Number: 2018-03239
Type: Rule
Date: 2018-02-16
Agency: Coast Guard, Department of Homeland Security
The Coast Guard is establishing a safety zone for all navigable waters on Pensacola Bay within 500 yards of the construction of the new Pensacola Bay Bridge in Pensacola, FL. The purpose of the safety zone is to protect personnel, vessels, and the marine environment from potential hazards created by work performed during the construction of the new bridge located across the Pensacola Bay. This rulemaking restricts speed to an idle speed or slowest safe speed for all vessels, mariners, and persons unless specifically authorized by the Captain of the Port Sector Mobile (COTP) or a designated representative.
Agency Information Collection Activities; Proposed eCollection eComments Requested; Approval of a New Collection
Document Number: 2018-03238
Type: Notice
Date: 2018-02-16
Agency: Department of Justice
The Department of Justice (DOJ), Federal Bureau of Investigation (FBI), Laboratory Division 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. This proposed information collection was previously published in the Federal Register allowing for a 60 day comment period.
Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
Document Number: 2018-03237
Type: Notice
Date: 2018-02-16
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Endocrinologic and Metabolic Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
Submission of Content Necessary for Bioresearch Monitoring Inspection Planning for the Center of Drug Evaluation and Research; Availability
Document Number: 2018-03236
Type: Notice
Date: 2018-02-16
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is announcing the availability of a draft guidance for industry entitled ``Standardized Format for Electronic Submission of NDA and BLA Content for the Planning of Bioresearch Monitoring (BIMO) Inspections for CDER Submissions'' along with the Bioresearch Monitoring Technical Conformance Guide Containing Technical Specifications (BIMO Technical Conformance Guide). The draft guidance and BIMO Technical Conformance Guide describe and provide specifications for the electronic submission of certain data and information in standardized formats. This information is used by the Center for Drug Evaluation and Research (CDER) in the planning of, and by FDA's Office of Regulatory Affairs (ORA) in the conduct of, bioresearch monitoring (BIMO) inspections. The draft guidance addresses major (i.e., pivotal) studies used to support safety and efficacy claims in new drug applications (NDAs) and biologics license applications (BLAs) regulated by CDER, as well as certain supplemental applications containing new clinical study reports. This draft guidance, when finalized, is intended to assist applicants in the submission of electronic data and information in standardized formats, and supersedes the previously issued draft guidance entitled ``Providing Submissions in Electronic FormatSummary Level Clinical Site Data for CDER's Inspection Planning'' (December 2012) (Summary Level Clinical Site Draft Guidance).
Russian Sanctions: Addition of Certain Entities to the Entity List
Document Number: 2018-03234
Type: Rule
Date: 2018-02-16
Agency: Department of Commerce, Bureau of Industry and Security
The Bureau of Industry and Security (BIS) with this final rule amends the Export Administration Regulations (EAR) by adding twenty-one entities to the Entity List. The twenty-one entities that are added to the Entity List have been determined by the U.S. Government to be acting contrary to the national security or foreign policy interests of the United States. BIS is taking this action to ensure the efficacy of existing sanctions on the Russian Federation (Russia) for violating international law and fueling the conflict in eastern Ukraine. These entities will be listed on the Entity List under the destinations of Georgia, Poland and Russia.
Announcement of Program for the Private Sector To Participate in Trade-Related Training of U.S. Customs and Border Protection and U.S. Immigration and Customs Enforcement Personnel
Document Number: 2018-03233
Type: Notice
Date: 2018-02-16
Agency: Department of Homeland Security, U.S. Customs and Border Protection, U.s. Immigration and Customs Enforcement
This document announces CBP's and ICE's process to solicit, evaluate, and select interested parties in the private sector to fulfill agency needs for instruction and related instructional materials for trade-related training, pursuant to section 104 of the Trade Facilitation and Trade Enforcement Act of 2015 (TFTEA).
Healthy Start Initiative: Eliminating Disparities in Perinatal Health Program Listening Session
Document Number: 2018-03232
Type: Notice
Date: 2018-02-16
Agency: Department of Health and Human Services, Health Resources and Services Administration
Pediatric Advisory Committee; Establishment of a Public Docket; Request for Comments; Amendment of Notice
Document Number: 2018-03231
Type: Notice
Date: 2018-02-16
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing an amendment to the notice of meeting of the Pediatric Advisory Committee (PAC). This meeting was announced in the Federal Register of January 2, 2018. The amendment is being made to reflect a change in the Center for Devices and Radiological Health (CDRH) products portion of the document and to include the topics that will be discussed during the meeting. There are no other changes.
How To Prepare a Pre-Request for Designation; Guidance for Industry; Availability
Document Number: 2018-03230
Type: Notice
Date: 2018-02-16
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``How to Prepare a Pre-Request for Designation (Pre-RFD).'' The purpose of this guidance is to explain the Pre-RFD process at the FDA Office of Combination Products (OCP), describe and help a sponsor understand the type of information that the sponsor should include in a Pre-RFD, and assist sponsors in obtaining a preliminary assessment from FDA through the Pre-RFD process. The Pre-RFD process is available to provide informal, non-binding feedback regarding the regulatory identity or classification of a human medical product as a drug, device, biological product, or combination product. In addition, this informal process provides information about a non-combination or combination product's assignment to the appropriate Agency Center (Center for Drug Evaluation and Research (CDER), Center for Devices and Radiological Health (CDRH), or Center for Biologics Evaluation and Research (CBER)) for premarket review and regulation.
Determination of Regulatory Review Period for Purposes of Patent Extension; HYMOVIS
Document Number: 2018-03229
Type: Notice
Date: 2018-02-16
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined the regulatory review period for HYMOVIS 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 medical device.