September 21, 2016 – Federal Register Recent Federal Regulation Documents

Reader Aids
Document Number: FR-2016-09-21-ReaderAids
Type: Reader Aids
Date: 2016-09-21
Northeast Canyons and Seamounts Marine National Monument
Document Number: 2016-22921
Type: Proclamation
Date: 2016-09-21
Agency: Executive Office of the President
Sunshine Act Meeting; Additional Item
Document Number: 2016-22906
Type: Notice
Date: 2016-09-21
Agency: Securities and Exchange Commission, Agencies and Commissions
Office of Hazardous Materials Safety Meeting
Document Number: 2016-22795
Type: Notice
Date: 2016-09-21
Agency: Federal Aviation Administration, Department of Transportation
In preparation for the International Civil Aviation Organization's (ICAO) Dangerous Goods Panel (DGP) meeting to be held October 17-October 21, 2016, in Montreal, Canada, the Federal Aviation Administration's (FAA) Office of Hazardous Materials Safety and the Pipeline and Hazardous Materials Safety Administration's (PHMSA) Office of Hazardous Materials Safety announce a public meeting.
Schedule of Charges Outside the United States
Document Number: 2016-22776
Type: Notice
Date: 2016-09-21
Agency: Federal Aviation Administration, Department of Transportation
The Federal Aviation Administration (FAA) is announcing the availability of Advisory Circular (AC) 187-1K which transmits an updated schedule of charges for services of FAA Flight Standards Aviation Safety Inspectors outside the United States. The advisory circular has been updated in accordance with the procedures listed in 14 CFR part 187, Appendix A.
Authorization of Subgrants for the Disability Innovation Fund-Automated Personalization Computing Project
Document Number: 2016-22774
Type: Notice
Date: 2016-09-21
Agency: Department of Education
This notice authorizes the use of subgrants with Disability Innovation FundAutomated Personalization Computing (APC) Project funds awarded to the Board of Regents of the University of Wisconsin System under CFDA number 84.421A, as provided by the Consolidated Appropriations Act, 2014, for the purpose of carrying out its proposed activities to implement a demonstration of automated personalization computing for individuals with disabilities.
Notice of Agreements Filed
Document Number: 2016-22773
Type: Notice
Date: 2016-09-21
Agency: Federal Maritime Commission, Agencies and Commissions
National Environmental Justice Advisory Council; Notification of Public Meeting and Public Comment
Document Number: 2016-22772
Type: Notice
Date: 2016-09-21
Agency: Environmental Protection Agency
Pursuant to the Federal Advisory Committee Act (FACA), Public Law 92-463, the U.S. Environmental Protection Agency (EPA) hereby provides notice that the National Environmental Justice Advisory Council (NEJAC) will meet on the dates and times described below. All meetings are open to the public. Members of the public are encouraged to provide comments relevant to the specific issues being considered by the NEJAC. For additional information about registering to attend the meeting or to provide public comment, please see ``REGISTRATION'' under SUPPLEMENTARY INFORMATION. Due to a limited space, seating at the NEJAC meeting will be on a first-come, first served basis. Pre-registration is highly suggested.
Notification of a Public Teleconference of the Great Lakes Advisory Board
Document Number: 2016-22771
Type: Notice
Date: 2016-09-21
Agency: Environmental Protection Agency
The Environmental Protection Agency (EPA) announces a teleconference of the Great Lakes Advisory Board (the Board). The purpose of this teleconference is to discuss the Great Lakes Restoration Initiative covering (GLRI) FY15-19 and other relevant matters.
Proposed Information Collection Request; Comment Request; Prevention of Significant Deterioration and Nonattainment New Source Review (Renewal)
Document Number: 2016-22770
Type: Notice
Date: 2016-09-21
Agency: Environmental Protection Agency
The Environmental Protection Agency (EPA) is planning to submit an information collection request (ICR), ``Prevention of Significant Deterioration and Nonattainment New Source Review'' (EPA ICR No. 1230.32, OMB Control No. 2060-0003) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.). Before doing so, the EPA is soliciting public comments on specific aspects of the proposed information collection as described below. This is a proposed extension of the ICR, which is currently approved through April 30, 2017. An agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.
Notice of Final Results of Antidumping Duty Changed Circumstances Review: Oil Country Tubular Goods From the Republic of Korea
Document Number: 2016-22768
Type: Notice
Date: 2016-09-21
Agency: Department of Commerce, International Trade Administration
On July 18, 2016, the Department of Commerce (the Department) published the notice of initiation and preliminary results of the changed circumstances review of the antidumping duty order on oil country tubular goods from the Republic of Korea (Korea). In that notice, we preliminarily determined that Hyundai Steel Corporation (Hyundai Steel) is the successor-in-interest to Hyundai HYSCO (HYSCO) for purposes of determining antidumping duty cash deposits and liabilities. No interested party submitted comments on the preliminary results. For these final results, the Department continues to find that Hyundai Steel is the successor-in-interest to HYSCO.
Membership of the Performance Review Board
Document Number: 2016-22766
Type: Notice
Date: 2016-09-21
Agency: Department of Education
The Secretary publishes a list of persons who may be named to serve on the Performance Review Board that oversees the evaluation of performance appraisals for Senior Executive Service members of the Department.
Product Cancellation Order for Certain Pesticide Registrations and Amendment To Terminate a Certain Use
Document Number: 2016-22764
Type: Notice
Date: 2016-09-21
Agency: Environmental Protection Agency
This notice announces EPA's order for the cancellations and amendment to terminate a certain use, voluntarily requested by the registrants and accepted by the Agency, of products containing the pesticides listed in Tables 1 and 2 of Unit II, pursuant to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). This cancellation order follows a July 21, 2016 Federal Register Notice of Receipt of Requests from the registrants listed in Table 3 of Unit II. to voluntarily cancel these product registrations, as well as to amend a registration to terminate a certain use of a product. In the July 21, 2016 Notice, EPA indicated that it would issue an order implementing the cancellations and amendment to terminate a certain use, unless the Agency received substantive comments within the 30 day comment period that would merit its further review of these requests, or unless the registrants withdrew their requests within this period. The Agency received one comment on the notice from a registrant to withdraw one cancellation request. Accordingly, EPA hereby issues in this notice a cancellation order granting the requested cancellations and amendment to terminate a certain use. Any distribution, sale, or use of the products subject to this cancellation order is permitted only in accordance with the terms of this order, including any existing stocks provisions.
Bureau of Political-Military Affairs, Directorate of Defense Trade Controls: Notifications to the Congress of Proposed Commercial Export Licenses
Document Number: 2016-22763
Type: Notice
Date: 2016-09-21
Agency: Department of State
Notice is hereby given that the Department of State has forwarded the attached Notifications of Proposed Export Licenses to the Congress on the dates indicated on the attachments pursuant to sections 36(c) and 36(d), and in compliance with section 36(f), of the Arms Export Control Act.
Correction; Summitec Corporation, Versar, Inc., and CDM/CSS-Dynamac Joint Venture; Transfer of Data
Document Number: 2016-22762
Type: Notice
Date: 2016-09-21
Agency: Environmental Protection Agency
This is a correction to the notice that published in the Federal Register of August 10, 2016, which announced that pesticide related information submitted to EPA's Office of Pesticide Programs (OPP) pursuant to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug, and Cosmetic Act (FFDCA), including information that may have been claimed as Confidential Business Information (CBI) by the submitter, will be transferred in accordance with the CBI regulations. That notice incorrectly identified the contractor as ``Summitec Corporation and listed its subcontractors as Versar, Inc., and CDM/CSS-Dynamac Joint Venture. In this notice, EPA is correctly listing the main contractors as Summitec Corporation, Versar, Inc. and CDM/CSS-Dynamac Joint Venture; and is also providing their respective subcontractors. This document corrects the listings in the notice of August 10, 2016.
Submission for OMB Review; Comment Request
Document Number: 2016-22759
Type: Notice
Date: 2016-09-21
Agency: Department of the Treasury
Certain Personal Transporters and Components Thereof Institution of Investigation
Document Number: 2016-22758
Type: Notice
Date: 2016-09-21
Agency: International Trade Commission, Agencies and Commissions
Notice is hereby given that a complaint was filed with the U.S. International Trade Commission on August 16, 2016, under section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337, on behalf of Segway Inc. of Bedford, New Hampshire; DEKA Products Limited Partnership of Manchester, New Hampshire; and Ninebot (Tianjin) Technology Co., Ltd. of China. A supplement to the complaint was filed on September 2, 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 personal transporters and components thereof by reason of infringement of U.S. Patent No. 6,302,230 (``the '230 patent'') and U.S. Patent No. 7,275,607 (``the '607 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 general exclusion order, or in the alternative a limited exclusion order, and cease and desist orders.
3206-0235, Letter Reply To Request for Information, RI 20-64; Former Spouse Survivor Annuity Election, RI 20-64A; Information on Electing a Survivor Annuity for Your Former Spouse, RI 20-64B
Document Number: 2016-22757
Type: Notice
Date: 2016-09-21
Agency: Office of Personnel Management
The Retirement Services, Office of Personnel Management (OPM) offers the general public and other Federal agencies the opportunity to comment on an extension, without change, of a currently approved information collection request, (ICR) OMB No. 3206-0235, Letter Reply to Request for Information, Form RI 20-64 and Information on Electing a Survivor Annuity for Your Former Spouse, Form RI 20-64A. As required by the Paperwork Reduction Act of 1995 (Pub. L. 104-13, 44 U.S.C. chapter 35) as amended by the Clinger-Cohen Act (Pub. L. 104-106), OPM is soliciting comments for this collection.
3206-0136, Designation of Beneficiary: Federal Employees' Group Life Insurance, SF 2823
Document Number: 2016-22756
Type: Notice
Date: 2016-09-21
Agency: Office of Personnel Management
The Retirement Services, Office of Personnel Management (OPM) offers the general public and other federal agencies the opportunity to comment on a revised information collection request (ICR) OMB No. 3206- 0136, Designation of Beneficiary: Federal Employees' Group Life Insurance, SF 2823. As required by the Paperwork Reduction Act of 1995, (Pub. L. 104-13, 44 U.S.C. chapter 35) as amended by the Clinger-Cohen Act (Pub. L. 104-106), OPM is soliciting comments for this collection.
3206-0216, We Need Important Information About Your Eligibility for Social Security Disability Benefits, RI 98-7
Document Number: 2016-22755
Type: Notice
Date: 2016-09-21
Agency: Office of Personnel Management
The Retirement Services, Office of Personnel Management (OPM) offers the general public and other federal agencies the opportunity to comment on an extension, without change, of a currently approved information collection request (ICR) OMB No. 3206-0216, We Need Important Information About Your Eligibility for Social Security Disability Benefits, RI 98-7. As required by the Paperwork Reduction Act of 1995, (Pub. L. 104-13, 44 U.S.C. chapter 35) as amended by the Clinger-Cohen Act (Pub. L. 104-106), OPM is soliciting comments for this collection.
Endangered and Threatened Wildlife and Plants; Endangered Species Status for Sonoyta Mud Turtle
Document Number: 2016-22754
Type: Proposed Rule
Date: 2016-09-21
Agency: Fish and Wildlife Service, Department of the Interior
We, the U.S. Fish and Wildlife Service (Service), propose to list the Sonoyta mud turtle (Kinosternon sonoriense longifemorale), a native subspecies from Arizona in the United States and Sonora in Mexico, as an endangered species under the Endangered Species Act (Act). If we finalize this rule as proposed, it would extend the Act's protections to this subspecies. The effect of this regulation will be to add this subspecies to the List of Endangered and Threatened Wildlife.
3206-0032, Self-Certification of Full-Time School Attendance For The School Year, RI 25-14 and Information and Instructions for Completing the Self-Certification of Full-Time School Attendance For The School Year, RI 25-14A
Document Number: 2016-22753
Type: Notice
Date: 2016-09-21
Agency: Office of Personnel Management
The Retirement Services, Office of Personnel Management (OPM) offers the general public and other federal agencies the opportunity to comment on an extension, without change, of a currently approved information collection request (ICR) 3206-0032, Self-Certification of Full-Time School Attendance For The School Year, RI 25-14 and Information and Instructions for Completing the Self-Certification of Full-Time School Attendance For The School Year, RI 25-14A. As required by the Paperwork Reduction Act of 1995, (Pub. L. 104-13, 44 U.S.C. chapter 35) as amended by the Clinger-Cohen Act (Pub. L. 104-106), OPM is soliciting comments for this collection.
Endangered and Threatened Wildlife and Plants; Threatened Species Status for Pearl Darter
Document Number: 2016-22752
Type: Proposed Rule
Date: 2016-09-21
Agency: Fish and Wildlife Service, Department of the Interior
We, the U.S. Fish and Wildlife Service (Service), propose to list the Pearl darter (Percina aurora), a fish from Mississippi, as a threatened species under the Endangered Species Act (Act). If we finalize this rule as proposed, it would extend the Act's protections to this species. The effect of this proposed regulation will be to add this species to the List of Endangered and Threatened Wildlife.
Drug Enforcement Administration
Document Number: 2016-22751
Type: Notice
Date: 2016-09-21
Agency: Department of Justice
Orders Granting Authority To Import and Export Natural Gas, To Import and Export Liquefied Natural Gas, and To Vacate Prior Authorization, During August 2016
Document Number: 2016-22750
Type: Notice
Date: 2016-09-21
Agency: Department of Energy
The Office of Fossil Energy (FE) of the Department of Energy gives notice that during August 2016, it issued orders granting authority to import and export natural gas, to import and export liquefied natural gas (LNG), and to vacate prior authority. These orders are summarized in the attached appendix and may be found on the FE Web site at http://energy.gov/fe/listing-doefe-authorizationsorders- issued-2016. They are also available for inspection and copying in the U.S. Department of Energy (FE-34), Division of Natural Gas Regulation, Office of Regulation and International Engagement, Office of Fossil Energy, Docket Room 3E-033, Forrestal Building, 1000 Independence Avenue SW., Washington, DC 20585, (202) 586-9478. The Docket Room is open between the hours of 8:00 a.m. and 4:30 p.m., Monday through Friday, except Federal holidays.
Publication of Depreciation Rates
Document Number: 2016-22747
Type: Notice
Date: 2016-09-21
Agency: Department of Agriculture, Rural Utilities Service
The United States Department of Agriculture (USDA) Rural Utilities Service (RUS) administers rural utilities programs, including the Telecommunications Program. RUS announces the depreciation rates for telecommunications plant for the period ending December 31, 2015.
Domestic Dates Produced or Packed in Riverside County, California; Decreased Assessment Rate
Document Number: 2016-22745
Type: Rule
Date: 2016-09-21
Agency: Agricultural Marketing Service, Department of Agriculture
This rule implements a recommendation from the California Date Administrative Committee (committee) for a decrease in the assessment rate established for the 2016-17 and subsequent crop years from $0.10 to $0.05 per hundredweight of dates handled. The committee locally administers the marketing order, which regulates the handling of dates produced or packed in Riverside County, California. Assessments upon date handlers are used by the committee to fund reasonable and necessary expenses of the program. The crop year begins October 1 and ends September 30. The assessment rate will remain in effect indefinitely unless modified, suspended, or terminated.
Nuclear Power Plant Instrumentation for Earthquakes
Document Number: 2016-22743
Type: Notice
Date: 2016-09-21
Agency: Nuclear Regulatory Commission, Agencies and Commissions
The U.S. Nuclear Regulatory Commission (NRC) is issuing for public comment draft regulatory guide (DG)-1332, ``Nuclear Power Plant Instrumentation for Earthquakes.'' This DG is proposed Revision 3 of Regulatory Guide 1.12, ``Nuclear Power Plant Instrumentation for Earthquakes.'' The NRC proposes to revise the guide to incorporate advances in seismic instrumentation and operating experience since Revision 2 of RG 1.12 was issued in 1997. The proposed revision describes the seismic instrumentation criteria, including instrumentation type, locations, characteristics, and maintenance, that the NRC staff considers acceptable for nuclear power plants.
Cherries Grown in Designated Counties in Washington; Increased Assessment Rate
Document Number: 2016-22740
Type: Proposed Rule
Date: 2016-09-21
Agency: Agricultural Marketing Service, Department of Agriculture
This proposed rule would implement a recommendation from the Washington Cherry Marketing Committee (Committee) to increase the assessment rate established for the 2016-2017 and subsequent fiscal periods from $0.15 to $0.25 per ton of Washington cherries handled. The Committee locally administers the marketing order and is comprised of growers and handlers of cherries operating within the production area. Assessments upon cherry handlers are used by the Committee to fund reasonable and necessary expenses of the marketing order. The fiscal period begins April 1 and ends March 31. The assessment rate would remain in effect indefinitely unless modified, suspended or terminated.
Notice of Availability of the Final Environmental Assessment (EA) and Finding of No Significant Impact/Record of Decision (FONSI/ROD) for the Runway 13/31 Shift/Extension and Associated Improvements Project for the Detroit Lakes-Becker County Airport (DTL) in Detroit Lakes, MN
Document Number: 2016-22739
Type: Notice
Date: 2016-09-21
Agency: Federal Aviation Administration, Department of Transportation
The FAA is issuing this notice to advise the public that the FAA has prepared and approved (August 23, 2016) a FONSI/ROD based on the Final EA for the DTL Runway 13/31 Shift/Extension and Associated Improvements Project. The Final EA was prepared in accordance with the National Environmental Policy Act (NEPA) of 1969, as amended, FAA Orders 1050.1F, ``Environmental Impacts: Policies and Procedures'' and 5050.4B, ``NEPA Implementing Instructions for Airport Actions''.
Bulk Manufacturer of Controlled Substances Application: Nanosyn, Inc.
Document Number: 2016-22737
Type: Notice
Date: 2016-09-21
Agency: Drug Enforcement Administration, Department of Justice
Formations of, Acquisitions by, and Mergers of Bank Holding Companies
Document Number: 2016-22733
Type: Notice
Date: 2016-09-21
Agency: Federal Reserve System, Agencies and Commissions
Eligibility of Independent Students for Assisted Housing Under Section 8 of the U.S. Housing Act of 1937; Additional Supplementary Guidance
Document Number: 2016-22727
Type: Notice
Date: 2016-09-21
Agency: Department of Housing and Urban Development
On December 30, 2005, HUD published a final rule (FR-5036-F- 01), ``Eligibility of Students for Assisted Housing under Section 8 of the U.S. Housing Act of 1937'', implementing section 327 of the agency's Fiscal Year 2006 appropriations, Title III of Public Law 109- 115, 119 Stat. 2936, approved November 30, 2005 (2006 HUD Appropriations Act). Section 327 requires that if an individual is enrolled at an institution of higher education (i.e., student) is under the age of 24, is not a veteran, is unmarried and does not have a dependent child, is individually ineligible for assistance under section 8 of the United States Housing Act of 1937 (section 8 assistance), or the student's parents are, individually or jointly, ineligible for assistance, no section 8 assistance can be provided to the student. On April 10, 2006, HUD published supplemental guidance to assist providers in implementing the final rule. That supplemental guidance provided a list of items that Public Housing Agencies, Owners, and Managers are required to verify when determining whether a student's income alone should be used to determine section 8 eligibility, and this notice updates that list of items to remain consistent with the U.S. Department of Education's definition of ``independent student,'' and reduce barriers for vulnerable youth to receive assistance and continue their education.
Fisheries of the Exclusive Economic Zone Off Alaska; Shortraker Rockfish in the Western Regulatory Area of the Gulf of Alaska
Document Number: 2016-22724
Type: Rule
Date: 2016-09-21
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
NMFS is prohibiting retention of shortraker rockfish in the Western Regulatory Area of the Gulf of Alaska (GOA). This action is necessary because the 2016 total allowable catch of shortraker rockfish in the Western Regulatory Area of the GOA will be reached.
60-Day Notice of Proposed Information Collection: Small Area Fair Market Rent Demonstration Evaluation
Document Number: 2016-22722
Type: Notice
Date: 2016-09-21
Agency: Department of Housing and Urban Development
HUD is seeking approval from the Office of Management and Budget (OMB) for the information collection described below. In accordance with the Paperwork Reduction Act, HUD is requesting comment from all interested parties on the proposed collection of information. The purpose of this notice is to allow for 60 days of public comment.
Passenger Facility Charge (PFC) Program; Draft FAA Order 5500.1B
Document Number: 2016-22721
Type: Notice
Date: 2016-09-21
Agency: Federal Aviation Administration, Department of Transportation
FAA is extending the comment period on the draft FAA Order 5500.1B, Passenger Facility Charge published on August 5, 2016. This draft Order clarifies and updates statutory and regulatory requirements, including those affected by changes to the PFC statute from multiple FAA reauthorizations.
Notice of Receipt of Petition for Decision that Nonconforming Model Year 2009 Jeep Compass Multipurpose Passenger Vehicles Are Eligible for Importation
Document Number: 2016-22720
Type: Notice
Date: 2016-09-21
Agency: National Highway Traffic Safety Administration, Department of Transportation
This document announces receipt by the National Highway Traffic Safety Administration (NHTSA) of a petition for a decision that model year (MY) 2009 Jeep Compass multipurpose passenger vehicles (MPVs) that were not originally manufactured to comply with all applicable Federal motor vehicle safety standards (FMVSS), are eligible for importation into the United States because they are substantially similar to vehicles that were originally manufactured for sale in the United States and that were certified by their manufacturer as complying with the safety standards (the U.S.-certified version of the 2009 Jeep Compass MPVs) and they are capable of being readily altered to conform to the standards.
60-Day Notice of Proposed Information Collection: Disaster Recovery Grant Reporting System
Document Number: 2016-22719
Type: Notice
Date: 2016-09-21
Agency: Department of Housing and Urban Development
HUD is seeking approval from the Office of Management and Budget (OMB) for the information collection described below. In accordance with the Paperwork Reduction Act, HUD is requesting comment from all interested parties on the proposed collection of information. The purpose of this notice is to allow for 60 days of public comment.
New Postal Products
Document Number: 2016-22718
Type: Notice
Date: 2016-09-21
Agency: Postal Regulatory Commission, Agencies and Commissions
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.
Renewal of the Agricultural Advisory Committee
Document Number: 2016-22717
Type: Notice
Date: 2016-09-21
Agency: Commodity Futures Trading Commission, Agencies and Commissions
The Commodity Futures Trading Commission (Commission) is publishing this notice to announce the renewal of the Agricultural Advisory Committee (AAC). The Commission has determined that the renewal of the AAC is necessary and in the public's interest, and the Commission has consulted with the General Services Administration's Committee Management Secretariat regarding the AAC's renewal.
National Commission on Forensic Science Solicitation of Applications for Additional Commission Membership To Support Medicolegal Death Investigation
Document Number: 2016-22715
Type: Notice
Date: 2016-09-21
Agency: Department of Justice
Pursuant to the Federal Advisory Committee Act, as amended, this notice announces the solicitation of applications for additional Commission membership specifically to fill a current forensic pathologist Commissioner vacancy to support medicolegal death investigation.
Procedures for Commission Review of State Opt-Out Requests From the FirstNet Radio Access Network
Document Number: 2016-22714
Type: Proposed Rule
Date: 2016-09-21
Agency: Federal Communications Commission, Agencies and Commissions
In this document the Commission opens a new proceeding relating to the National Public Safety Broadband Network being implemented by the First Responder Network Authority (FirstNet). The proceeding seeks comment on proposed procedures for administering the Commission's role in the State opt-out process from the FirstNet radio access network as provided under the Middle Class Tax Relief and Job Creation Act of 2012, as well as on the Commission's implementation of the specific statutory standards by which it is obligated to evaluate State opt-out applications.
Advisory Board on Toxic Substances and Worker Health
Document Number: 2016-22712
Type: Notice
Date: 2016-09-21
Agency: Department of Labor, Office of Workers' Compensation Programs
The Advisory Board will meet October 17-19, 2016, in Oak Ridge, Tennessee. Comments, requests to speak, submissions of materials for the record, and requests for special accommodations: You must submit (postmark, send, transmit) comments, requests to address the Advisory Board, speaker presentations, and requests for special accommodations for the meetings by October 7, 2016.
Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2016-22711
Type: Notice
Date: 2016-09-21
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 entitled ``Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices.'' This draft guidance is intended to assist drug sponsors and device manufacturers who are planning to develop new antimicrobial drugs and antimicrobial susceptibility test (AST) devices and who seek to coordinate development of these products such that the AST device could be cleared either at the time of new drug approval or shortly thereafter. This draft guidance is not final nor is it in effect at this time.
Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 045
Document Number: 2016-22710
Type: Notice
Date: 2016-09-21
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing a publication containing modifications the Agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA Recognized Consensus Standards). This publication, entitled ``Modifications to the List of Recognized Standards, Recognition List Number: 045'' (Recognition List Number: 045), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.