September 2018 – Federal Register Recent Federal Regulation Documents

Results 401 - 450 of 2,138
Notice of Determinations; Culturally Significant Objects Imported for Exhibition-Determinations: “Metaphysical Masterpieces 1916-1920: Morandi, Sironi, and Carrà” Exhibition
Document Number: 2018-20813
Type: Notice
Date: 2018-09-25
Agency: Department of State
Notice is hereby given of the following determinations: I hereby determine that certain objects to be included in the exhibition ``Metaphysical Masterpieces 1916-1920: Morandi, Sironi, and Carr[agrave],'' imported from abroad for temporary exhibition within the United States, are of cultural significance. The objects are imported pursuant to a loan agreement with the foreign owner or custodian. I also determine that the exhibition or display of the exhibit objects at the Center for Italian Modern Art, New York, New York, from on or about October 19, 2018, until on or about June 15, 2019, and at possible additional exhibitions or venues yet to be determined, is in the national interest. I have ordered that Public Notice of these determinations be published in the Federal Register.
Notice of Determinations; Culturally Significant Objects Imported for Exhibition-Determinations: “East Meets West: Jewels of the Maharajas From the Al Thani Collection” Exhibition
Document Number: 2018-20812
Type: Notice
Date: 2018-09-25
Agency: Department of State
Notice is hereby given of the following determinations: I hereby determine that certain objects to be included in the exhibition ``East Meets West: Jewels of the Maharajas from the Al Thani Collection,'' imported from abroad for temporary exhibition within the United States, are of cultural significance. The objects are imported pursuant to loan agreements with the foreign owners or custodians. I also determine that the exhibition or display of the exhibit objects at the Fine Arts Museums of San Francisco, Legion of Honor Museum, San Francisco, California, from on or about November 3, 2018, until on or about February 24, 2019, and at possible additional exhibitions or venues yet to be determined, is in the national interest. I have ordered that Public Notice of these determinations be published in the Federal Register.
Notice of Determinations; Culturally Significant Object Imported for Exhibition-Determinations: “Myth and Faith in Renaissance Florence” Exhibition
Document Number: 2018-20811
Type: Notice
Date: 2018-09-25
Agency: Department of State
Notice is hereby given of the following determinations: I hereby determine that a certain object to be included in the exhibition ``Myth and Faith in Renaissance Florence,'' imported from abroad for temporary exhibition within the United States, is of cultural significance. The object is imported pursuant to a loan agreement with the foreign owner or custodian. I also determine that the exhibition or display of the exhibit object at the Currier Museum of Art, Manchester, New Hampshire, from on or about October 13, 2018, until on or about January 21, 2019, and at possible additional exhibitions or venues yet to be determined, is in the national interest. I have ordered that Public Notice of these determinations be published in the Federal Register.
Notice of Determinations; Culturally Significant Objects Re-Imported for Exhibition-Determinations: “Keir Collection of Art of the Islamic World” Exhibitions
Document Number: 2018-20810
Type: Notice
Date: 2018-09-25
Agency: Department of State
Notice is hereby given of the following determinations: I hereby determine that two objects to be included in exhibitions of the Keir Collection of Art of the Islamic World, re-imported from abroad for temporary exhibition within the United States, are of cultural significance. The objects are re-imported pursuant to a loan agreement with the foreign owner or custodian. I also determine that the exhibition or display of the first object at the Dallas Museum of Art, in Dallas, Texas, and at possible additional exhibitions or venues yet to be determined, from on or about September 21, 2018, until on or about May 4, 2020, is in the national interest. I also determine that the exhibition or display of the second object at the Dallas Museum of Art, and at possible additional exhibitions or venues yet to be determined, from on or about September 21, 2018, until on or about October 13, 2020, is in the national interest. I have ordered that Public Notice of these determinations be published in the Federal Register.
Agency Forms Undergoing Paperwork Reduction Act Review; Withdraw
Document Number: 2018-20809
Type: Notice
Date: 2018-09-25
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) announces the withdrawal of the notice published under the same title on September 7, 2018 for public comment.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2018-20808
Type: Notice
Date: 2018-09-25
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled ``Maritime Illness Database and Reporting System (MIDRS)''. The purpose of this data collection is to provide U.S.-bound passenger vessel operators an electronic reporting system to assist with their legal requirement to notify CDC of the number of passengers and crew members onboard their ship who have reportable acute gastroenteritis (AGE) as defined by federal quarantine regulations.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2018-20807
Type: Notice
Date: 2018-09-25
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Notice of Determinations; Culturally Significant Objects Imported for Exhibition-Determinations: “Underworld: Imagining the Afterlife” Exhibition
Document Number: 2018-20806
Type: Notice
Date: 2018-09-25
Agency: Department of State
Notice is hereby given of the following determinations: I hereby determine that certain objects to be included in the exhibition ``Underworld: Imagining the Afterlife,'' imported from abroad for temporary exhibition within the United States, are of cultural significance. The objects are imported pursuant to loan agreements with the foreign owners or custodians. I also determine that the exhibition or display of the exhibit objects at The J. Paul Getty Museum at the Getty Villa, Los Angeles, California, from on or about October 31, 2018, until on or about March 18, 2019, and at possible additional exhibitions or venues yet to be determined, is in the national interest. I have ordered that Public Notice of these determinations be published in the Federal Register.
Calendar of June 2018 Approved International Trade Administration Trade Missions
Document Number: 2018-20805
Type: Notice
Date: 2018-09-25
Agency: Department of Commerce, International Trade Administration
The United States Department of Commerce, International Trade Administration (ITA) is announcing three upcoming trade missions that will be recruited, organized, and implemented by ITA. These missions are:
Meetings of the United States-Panama Environmental Affairs Council and Environmental Cooperation Commission
Document Number: 2018-20803
Type: Notice
Date: 2018-09-25
Agency: Department of State
The Department of State and the Office of the United States Trade Representative (USTR) are providing notice that the United States and Panama intend to hold the second meetings of the Environmental Affairs Council (the ``Council'') and the Environmental Cooperation Commission (the ``Commission'') on October 3, 2018. The public sessions for the Council and Commission will be held on October 3, 2018, in Panama City, Panama. The purpose of the meetings is to review implementation of Chapter 17 (Environment) of the United States-Panama Trade Promotion Agreement (TPA) and the United States-Panama Environmental Cooperation Agreement (ECA). The Department of State and USTR invite interested organizations and members of the public to attend the public sessions and to submit written comments or suggestions regarding topics to be discussed at the meetings. If you would like to attend the public session, please notify Neal Morris and Laura Buffo at the email addresses listed below under the heading ADDRESSES. Please include your full name and any organization or group you represent. In preparing comments, submitters are encouraged to refer to: Chapter 17 of the TPA, https://ustr.gov/sites/default/ files/uploads/agreements/fta/panama/asset_upload_file314_1040 0.pdf; and the ECA http://www.state.gov/documents/organization/ 189455.pdf. These and other useful documents are available at https://ustr.gov/ trade-agreements/free-trade-agreements/panama-tpa and at http:// www.state.gov/e/oes/eqt/trade/panama/index.htm.
Airworthiness Directives; Viking Air Limited Airplanes
Document Number: 2018-20802
Type: Rule
Date: 2018-09-25
Agency: Federal Aviation Administration, Department of Transportation
We are adopting a new airworthiness directive (AD) for all Viking Air Limited Models DHC-2 Mk. I, DHC-2 Mk. II, and DHC-2 Mk. III airplanes. This AD results from mandatory continuing airworthiness information (MCAI) issued by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as cracking found in the wing rear spar web at the wing station where the flap outboard hinge is attached. We are issuing this AD to require actions to address the unsafe condition on these products.
Notice of Final Federal Agency Actions on Proposed Highway Projects in Texas
Document Number: 2018-20801
Type: Notice
Date: 2018-09-25
Agency: Department of Transportation
This notice announces actions taken by TxDOT and Federal agencies that are final. The environmental review, consultation, and other actions required by applicable Federal environmental laws for these projects are being, or have been, carried-out by TxDOT and a Memorandum of Understanding dated December 16, 2014, and executed by FHWA and TxDOT. The actions relate to various proposed highway projects in the State of Texas. Those actions grant licenses, permits, and approvals for the projects.
Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Oil-Spill Response Requirements for Facilities Located Seaward of the Coast Line
Document Number: 2018-20800
Type: Notice
Date: 2018-09-25
Agency: Department of the Interior
In accordance with the Paperwork Reduction Act of 1995, the Bureau of Safety and Environmental Enforcement (BSEE) proposes to renew an information collection.
Aquatic Nuisance Species Task Force Meeting
Document Number: 2018-20799
Type: Notice
Date: 2018-09-25
Agency: Fish and Wildlife Service, Department of the Interior
We, the U.S. Fish and Wildlife Service (Service), announce a teleconference/web meeting of the Aquatic Nuisance Species (ANS) Task Force, in accordance with the Federal Advisory Committee Act. The ANS Task Force's purpose is to develop and implement a program for U.S. waters to prevent introduction and dispersal of aquatic invasive species; to monitor, control, and study such species; and to disseminate related information.
Notice is Given of the Names of Members of the Performance Review Board for the Department of the Air Force
Document Number: 2018-20798
Type: Notice
Date: 2018-09-25
Agency: Department of Defense, Department of the Air Force
Notice is given of the names of members of the 2018 Performance Review Board for the Department of the Air Force. Applicable Dates: November 5, 2018.
Bureau of Consular Affairs; Registration for the Diversity Immigrant (DV-2020) Visa Program
Document Number: 2018-20796
Type: Notice
Date: 2018-09-25
Agency: Department of State
This public notice provides information on how to apply for the DV-2020 Program and is issued pursuant to the Immigration and Nationality Act.
Pediatric Medical Device Development; Public Meeting; Request for Comments; Reopening of Comment Period
Document Number: 2018-20795
Type: Notice
Date: 2018-09-25
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is reopening the comment period provided in the notice entitled ``Pediatric Medical Device Development; Public Meeting; Request for Comments'' that appeared in the Federal Register on February 16, 2018. That notice announced the public meeting to be held on August 13 and 14, 2018, and requested comments by September 14, 2018. FDA is reopening the public meeting's comment period until November 26, 2018. The Agency is taking this action to allow interested parties additional time to submit comments.
Safety Zone; Lower Mississippi River, Mile Markers 94 to 95 Above Head of Passes, New Orleans, LA
Document Number: 2018-20794
Type: Rule
Date: 2018-09-25
Agency: Coast Guard, Department of Homeland Security
The Coast Guard is establishing a temporary safety zone for certain navigable waters of the Lower Mississippi River. This action is necessary to provide for the safety of persons, vessels, and the marine environment on these navigable waters near New Orleans, LA, during a fireworks display on October 6, 2018. This regulation prohibits persons and vessels from being in the safety zone unless authorized by the Captain of the Port Sector New Orleans or a designated representative.
Cameco Resources; Smith Ranch-Highland Uranium Project
Document Number: 2018-20793
Type: Notice
Date: 2018-09-25
Agency: Nuclear Regulatory Commission, Agencies and Commissions
The U.S. Nuclear Regulatory Commission (NRC) is considering the renewal of NRC source materials license SUA-1548, to authorize continued uranium in-situ recovery (ISR) operations at the sites under the Smith Ranch-Highland Uranium Project (Smith Ranch Project) (Docket No. 40-8964). The NRC has prepared an Environmental Assessment (EA) and Finding of No Significant Impact (FONSI) for this licensing action.
Information Collection: NRC Form 361, Reactor Plant Event Notification Worksheet; NRC Form 361A, Fuel Cycle and Materials Event Notification Worksheet; NRC Form 361N, Non-Power Reactor Event Notification Worksheet
Document Number: 2018-20792
Type: Notice
Date: 2018-09-25
Agency: Nuclear Regulatory Commission, Agencies and Commissions
The U.S. Nuclear Regulatory Commission (NRC) invites public comment on this proposed collection of information. The information collection is entitled, ``NRC Form 361, Reactor Plant Event Notification Worksheet; NRC Form 361A, Fuel Cycle and Materials Event Notification Worksheet; NRC Form 361N, Non-Power Reactor Event Notification Worksheet.''
Abbreviated New Drug Application Submissions-Content and Format; Guidance for Industry; Availability
Document Number: 2018-20790
Type: Notice
Date: 2018-09-25
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``ANDA SubmissionsContent and Format.'' This guidance is intended to assist applicants in preparing abbreviated new drug applications (ANDAs) for submission to FDA under the Federal Food, Drug and Cosmetic Act (the FD&C Act).
Good Review Management Principles and Practices for New Drug Applications and Biologics License Applications; Draft Guidance for Industry and Review Staff; Availability
Document Number: 2018-20789
Type: Notice
Date: 2018-09-25
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry and review staff entitled ``Good Review Management Principles and Practices for New Drug Applications and Biologics License Applications.'' This draft guidance describes the fundamental values and operational principles that serve as the foundation for the review process. It also clarifies the roles and responsibilities of review staff and identifies ways in which applicants may support a robust and efficient review process. This draft guidance revises the guidance for review staff and industry entitled ``Good Review Management Principles and Practices for PDUFA Products'' issued April 2005.
Submission for OMB Review; Comment Request
Document Number: 2018-20788
Type: Notice
Date: 2018-09-25
Agency: Department of Commerce
Submission for OMB Review; Comment Request
Document Number: 2018-20787
Type: Notice
Date: 2018-09-25
Agency: Department of Commerce, Bureau of Economic Analysis
Submission for OMB Review; Comment Request
Document Number: 2018-20786
Type: Notice
Date: 2018-09-25
Agency: Department of Commerce
Submission for OMB Review; Comment Request
Document Number: 2018-20785
Type: Notice
Date: 2018-09-25
Agency: Department of Commerce
Submission for OMB Review; Comment Request
Document Number: 2018-20784
Type: Notice
Date: 2018-09-25
Agency: Department of Commerce
Submission for OMB Review; Comment Request
Document Number: 2018-20783
Type: Notice
Date: 2018-09-25
Agency: Department of Commerce, Bureau of Economic Analysis
Submission for OMB Review; Comment Request
Document Number: 2018-20782
Type: Notice
Date: 2018-09-25
Agency: Department of Commerce, International Trade Administration
Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; High School Longitudinal Study of 2009 (HSLS:09) Panel Maintenance 2018 and 2021
Document Number: 2018-20781
Type: Notice
Date: 2018-09-25
Agency: Department of Education
In accordance with the Paperwork Reduction Act of 1995, ED is proposing a revision of an existing information collection.
FDIC Advisory Committee on Community Banking; Notice of Meeting
Document Number: 2018-20780
Type: Notice
Date: 2018-09-25
Agency: Federal Deposit Insurance Corporation, Agencies and Commissions
In accordance with the Federal Advisory Committee Act, notice is hereby given of a meeting of the FDIC Advisory Committee on Community Banking, which will be held in Washington, DC. The Advisory Committee will provide advice and recommendations on a broad range of policy issues that have particular impact on small community banks throughout the United States and the local communities they serve, with a focus on rural areas.
Filing Dates for the New York Special Election in the 25th Congressional District
Document Number: 2018-20779
Type: Notice
Date: 2018-09-25
Agency: Federal Election Commission, Agencies and Commissions
New York has scheduled a special general election on November 6, 2018, to fill the U.S. House of Representatives seat in the 25th Congressional District of the late Representative Louise Slaughter. Committees required to file reports in connection with the Special General Election on November 6, 2018, shall file a 12-day Pre-General Report, and a 30-day Post-General Report.
Certain Semiconductor Devices and Consumer Audiovisual Products Containing the Same; Commission's Final Determination of No Violation of Section 337; Termination of the Investigation
Document Number: 2018-20778
Type: Notice
Date: 2018-09-25
Agency: International Trade Commission, Agencies and Commissions
Notice is hereby given that the U.S. International Trade Commission has found no violation of section 337 of the Tariff Act of 1930, as amended, by respondents Sigma Designs, Inc. and Vizio, Inc. The investigation is terminated.
Further Testing of Donations That Are Reactive on a Licensed Donor Screening Test for Antibodies to Hepatitis C Virus; Draft Guidance for Industry; Availability
Document Number: 2018-20776
Type: Notice
Date: 2018-09-25
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document entitled ``Further Testing of Donations that are Reactive on a Licensed Donor Screening Test for Antibodies to Hepatitis C Virus; Draft Guidance for Industry.'' The draft guidance document provides blood establishments that collect Whole Blood and blood components, including Source Plasma, with recommendations for further testing of donations that are reactive on a licensed donor screening test for antibodies to hepatitis C virus (anti-HCV). The draft guidance also provides guidance to blood establishments on how to report the implementation of these recommendations. The draft guidance, when finalized, will update the recommendations related to the use of an appropriate multiantigen supplemental test contained in ``Guidance for Industry: `Lookback' for Hepatitis C Virus (HCV): Product Quarantine, Consignee Notification, Further Testing, Product Disposition, and Notification of Transfusion Recipients Based on Donor Test Results Indicating Infection with HCV'' dated December 2010.
Recommendations for Requalification of Blood Donors Deferred Because of Reactive Test Results for Antibodies to Human T-Lymphotropic Virus Types I and II; Draft Guidance for Industry; Availability
Document Number: 2018-20775
Type: Notice
Date: 2018-09-25
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document entitled ``Recommendations for Requalification of Blood Donors Deferred Because of Reactive Test Results for Antibodies to Human T-Lymphotropic Virus Types I and II (anti-HTLV-I/II); Draft Guidance for Industry.'' The draft guidance document provides blood establishments that collect Whole Blood and blood components with recommendations for a requalification method for deferred donors, based on a determination that their previous reactive test results for anti-HTLV-I/II were falsely positive.
Environmental Technologies Trade Advisory Committee (ETTAC), Notice of Reestablishment and Solicitation of Nominations for Membership
Document Number: 2018-20774
Type: Notice
Date: 2018-09-25
Agency: Department of Commerce, International Trade Administration
Pursuant to provisions under Title IV of the Jobs Through Trade Expansion Act, and under the Federal Advisory Committee Act, the Department of Commerce announces the reestablishment of the Environmental Technologies Trade Advisory Committee (ETTAC), as of August 16, 2018. ETTAC was first chartered on May 31, 1994. ETTAC serves as an advisory body to the Environmental Trade Working Group of the Trade Promotion Coordinating Committee (TPCC), reporting directly to the Secretary of Commerce in his/her capacity as Chairman of the TPCC. ETTAC advises on the development and administration of policies and programs to expand U.S. exports of environmental technologies, goods, and services.
Notice of Funds Availability (NOFA); Market Facilitation Program (MFP) Payments to Producers
Document Number: 2018-20773
Type: Notice
Date: 2018-09-25
Agency: Department of Agriculture, Commodity Credit Corporation, Farm Service Agency
MFP provides payments to producers with commodities that have been significantly impacted by actions of foreign governments resulting in the loss of traditional exports. This NOFA announces the availability of MFP funds for eligible producers of shelled almonds and fresh sweet cherries and makes a correction to a previously issued NOFA published on August 30, 2018, with respect to MFP funds availability for hogs. On behalf of the Commodity Credit Corporation (CCC), the Farm Service Agency (FSA) administers MFP. MFP participants will receive an MFP payment, calculated based on the eligible production multiplied by the participant's share multiplied by the MFP payment rate.
Fee for Using a Tropical Disease Priority Review Voucher in Fiscal Year 2019
Document Number: 2018-20772
Type: Notice
Date: 2018-09-25
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is announcing the fee rates for using a tropical disease priority review voucher for fiscal year (FY) 2019. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Food and Drug Administration Amendments Act of 2007 (FDAAA), authorizes FDA to determine and collect priority review user fees for certain applications for review of drug or biological products when those applications use a tropical disease priority review voucher. These vouchers are awarded to the applicants of certain tropical disease product applications, submitted after September 27, 2007, upon FDA approval of such applications. The amount of the fee submitted to FDA with applications using a tropical disease priority review voucher is determined each fiscal year based on the difference between the average cost incurred by FDA to review a human drug application designated as priority review in the previous fiscal year and the average cost incurred in the review of an application that is not subject to priority review in the previous fiscal year. This notice establishes the tropical disease priority review fee rate for FY 2019.
Benefit-Risk Factors To Consider When Determining Substantial Equivalence in Premarket Notifications (510(k)) With Different Technological Characteristics; Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2018-20771
Type: Notice
Date: 2018-09-25
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of the final guidance entitled ``Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications (510(k)) with Different Technological Characteristics.'' This guidance document describes factors FDA considers when evaluating the benefit-risk profile of a device in comparison to a predicate device in a 510(k) when the device has the same intended use as the predicate device, and different technological characteristics that do not raise different questions of safety and effectiveness. This guidance can be helpful in situations when there is an increase in risk and increase or equivalent benefit, or a decrease in benefit and a decrease or equivalent risk when comparing a new device to a predicate device. FDA developed this guidance to improve the predictability, consistency, and transparency of the 510(k) premarket review process.
Listing of Color Additives Subject to Certification; D&C Yellow No. 8
Document Number: 2018-20767
Type: Rule
Date: 2018-09-25
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the expanded safe use of D&C Yellow No. 8 as a color additive in contact lens solution. We are taking this action in response to a color additive petition submitted by Glo Eyes, LLC.
Agency Information Collection Activities; Proposed Collection; Comment Request; Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act
Document Number: 2018-20766
Type: Notice
Date: 2018-09-25
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, Agency, or we) 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 collection of information associated with adverse event reporting and recordkeeping for dietary supplements as required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act (DSNDCPA).
Agency Information Collection Activities; Proposed Collection; Comment Request; Generic Drug User Fee Cover Sheet
Document Number: 2018-20765
Type: Notice
Date: 2018-09-25
Agency: Food and Drug Administration, Department of Health and Human Services
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 collection of information using Form FDA 3794, entitled ``Generic Drug User Fee Cover Sheet.''
Agency Information Collection Activities; Proposed Collection; Comment Request; Public Health Service Guideline on Infectious Disease Issues in Xenotransplantation
Document Number: 2018-20764
Type: Notice
Date: 2018-09-25
Agency: Food and Drug Administration, Department of Health and Human Services
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 this notice. This notice solicits comments on the collection of information contained in the Public Health Service (PHS) guideline entitled ``PHS Guideline on Infectious Disease Issues in Xenotransplantation'' dated January 19, 2001.
Ophthalmic Devices; Reclassification of Ultrasound Cyclodestructive Device
Document Number: 2018-20763
Type: Proposed Rule
Date: 2018-09-25
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is issuing this proposed order to reclassify the ultrasound cyclodestructive device, a postamendments class III device (regulated under product code LZR), into class II (special controls), subject to premarket notification. FDA is also identifying the proposed special controls that the Agency believes are necessary to provide a reasonable assurance of safety and effectiveness of the device. FDA is proposing this reclassification on its own initiative based on new information. If finalized, this order will reclassify these devices from class III to class II (special controls) and reduce regulatory burdens as these types of devices will no longer be required to submit a premarket approval application (PMA) but can instead submit a less burdensome premarket notification (510(k)) before marketing their device.