DOCSLIB.ORG

Vol. 85 Wednesday, No. 171 September 2, 2020 Pages 54481

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Vol. 85 Wednesday, No. 171 September 2, 2020 Pages 54481 Vol. 85 Wednesday, No. 171 September 2, 2020 Pages 54481–54884 OFFICE OF THE FEDERAL REGISTER VerDate Sep 11 2014 20:57 Sep 01, 2020 Jkt 250001 PO 00000 Frm 00001 Fmt 4710 Sfmt 4710 E:\FR\FM\02SEWS.LOC 02SEWS jbell on DSKJLSW7X2PROD with FR_WS II Federal Register / Vol. 85, No. 171 / Wednesday, September 2, 2020 The FEDERAL REGISTER (ISSN 0097–6326) is published daily, SUBSCRIPTIONS AND COPIES Monday through Friday, except official holidays, by the Office PUBLIC of the Federal Register, National Archives and Records Administration, under the Federal Register Act (44 U.S.C. Ch. 15) Subscriptions: and the regulations of the Administrative Committee of the Federal Paper or fiche 202–512–1800 Register (1 CFR Ch. I). The Superintendent of Documents, U.S. Assistance with public subscriptions 202–512–1806 Government Publishing Office, is the exclusive distributor of the official edition. Periodicals postage is paid at Washington, DC. General online information 202–512–1530; 1–888–293–6498 Single copies/back copies: The FEDERAL REGISTER provides a uniform system for making available to the public regulations and legal notices issued by Paper or fiche 202–512–1800 Federal agencies. These include Presidential proclamations and Assistance with public single copies 1–866–512–1800 Executive Orders, Federal agency documents having general (Toll-Free) applicability and legal effect, documents required to be published FEDERAL AGENCIES by act of Congress, and other Federal agency documents of public Subscriptions: interest. Assistance with Federal agency subscriptions: Documents are on file for public inspection in the Office of the Federal Register the day before they are published, unless the Email [email protected] issuing agency requests earlier filing. For a list of documents Phone 202–741–6000 currently on file for public inspection, see www.federalregister.gov. The seal of the National Archives and Records Administration The Federal Register Printing Savings Act of 2017 (Pub. L. 115- authenticates the Federal Register as the official serial publication 120) placed restrictions on distribution of official printed copies established under the Federal Register Act. Under 44 U.S.C. 1507, of the daily Federal Register to members of Congress and Federal the contents of the Federal Register shall be judicially noticed. offices. Under this Act, the Director of the Government Publishing The Federal Register is published in paper and on 24x microfiche. Office may not provide printed copies of the daily Federal Register It is also available online at no charge at www.govinfo.gov, a unless a Member or other Federal office requests a specific issue service of the U.S. Government Publishing Office. or a subscription to the print edition. For more information on how to subscribe use the following website link: https:// The online edition of the Federal Register is issued under the www.gpo.gov/frsubs. authority of the Administrative Committee of the Federal Register as the official legal equivalent of the paper and microfiche editions (44 U.S.C. 4101 and 1 CFR 5.10). It is updated by 6:00 a.m. each day the Federal Register is published and includes both text and graphics from Volume 1, 1 (March 14, 1936) forward. For more information, contact the GPO Customer Contact Center, U.S. Government Publishing Office. Phone 202-512-1800 or 866-512- 1800 (toll free). E-mail, gpocusthelp.com. The annual subscription price for the Federal Register paper edition is $860 plus postage, or $929, for a combined Federal Register, Federal Register Index and List of CFR Sections Affected (LSA) subscription; the microfiche edition of the Federal Register including the Federal Register Index and LSA is $330, plus postage. Six month subscriptions are available for one-half the annual rate. The prevailing postal rates will be applied to orders according to the delivery method requested. The price of a single copy of the daily Federal Register, including postage, is based on the number of pages: $11 for an issue containing less than 200 pages; $22 for an issue containing 200 to 400 pages; and $33 for an issue containing more than 400 pages. Single issues of the microfiche edition may be purchased for $3 per copy, including postage. Remit check or money order, made payable to the Superintendent of Documents, or charge to your GPO Deposit Account, VISA, MasterCard, American Express, or Discover. Mail to: U.S. Government Publishing Office—New Orders, P.O. Box 979050, St. Louis, MO 63197-9000; or call toll free 1-866-512-1800, DC area 202-512-1800; or go to the U.S. Government Online Bookstore site, see bookstore.gpo.gov. There are no restrictions on the republication of material appearing in the Federal Register. How To Cite This Publication: Use the volume number and the page number. Example: 85 FR 12345. Postmaster: Send address changes to the Superintendent of Documents, Federal Register, U.S. Government Publishing Office, Washington, DC 20402, along with the entire mailing label from the last issue received. VerDate Sep 11 2014 20:57 Sep 01, 2020 Jkt 250001 PO 00000 Frm 00002 Fmt 4710 Sfmt 4710 E:\FR\FM\02SEWS.LOC 02SEWS jbell on DSKJLSW7X2PROD with FR_WS III Contents Federal Register Vol. 85, No. 171 Wednesday, September 2, 2020 Agriculture Department Meetings: See Forest Service President’s Board of Advisors on Historically Black Colleges and Universities, 54540–54541 Alcohol and Tobacco Tax and Trade Bureau RULES Establishment of the Royal Slope Viticultural Area, 54491– Energy Department 54494 See Federal Energy Regulatory Commission See National Nuclear Security Administration Centers for Medicare & Medicaid Services NOTICES RULES Agency Information Collection Activities; Proposals, Medicare and Medicaid Programs, Clinical Laboratory Submissions, and Approvals, 54548–54549 Improvement Amendments, and Patient Protection and Environmental Impact Statements; Availability, etc.: Affordable Care Act: Continued Operation of Los Alamos National Laboratory, Additional Policy and Regulatory Revisions in Response Los Alamos, NM, 54544–54548 to the COVID–19 Public Health Emergency, 54820– Meetings: 54874 Environmental Management Site-Specific Advisory Board, Nevada, 54549 Coast Guard Environmental Management Site-Specific Advisory RULES Board, Northern New Mexico, 54544 Drawbridge Operations: Environmental Management Site-Specific Advisory Fox River, Oshkosh, WI, 54496–54497 Board, Savannah River Site, 54549 Safety Zones: Beals Island Bridge Demolition, Moosabec Reach, Jonesport, ME, 54499–54501 Environmental Protection Agency Delaware River Dredging, Marcus Hook, PA, 54501– RULES 54504 Air Quality State Implementation Plans; Approvals and I–5 Bridge Construction Project, Columbia River, Promulgations: Vancouver, WA, 54497–54499 Kentucky; Jefferson County Existing and New Special Local Regulations: Miscellaneous Metal Parts and Products Surface Atlantic Intracoastal Waterway, Morehead City, NC, Coating Operations, 54510–54513 54494–54496 Kentucky; Prevention of Significant Deterioration and NOTICES Modeling Infrastructure Requirements for 2015 Meetings: Ozone National Ambient Air Quality Standards, Commercial Fishing Safety Advisory Committee, 54587 54507–54509 Texas; Beaumont-Port Arthur Area Second Maintenance Commerce Department Plan for 1997 Ozone National Ambient Air Quality See International Trade Administration Standards, 54504–54507 See National Oceanic and Atmospheric Administration Determination of Failure To Attain by the Attainment Date Defense Department and Denial of Serious Area Attainment Date Extension See Navy Department Request: Alaska: Fairbanks North Star Borough 2006 24-Hour Fine Education Department Particulate Matter Serious Nonattainment Area, RULES 54509–54510 Distance Education and Innovation, 54742–54818 PROPOSED RULES NOTICES Redesignation of Certain Unclassifiable Areas for the 2010 Agency Information Collection Activities; Proposals, 1-Hour Sulfur Dioxide Primary National Ambient Air Submissions, and Approvals: Quality Standard, 54517–54523 2020/22 Beginning Postsecondary Students Field Test, NOTICES 54539 Agency Information Collection Activities; Proposals, Evaluation of the Innovative Assessment Demonstration Submissions, and Approvals: Authority Pilot Program-Survey Data Collection, Public Notification Requirements for Combined Sewer 54541–54542 Overflows in the Great Lakes Basin, 54574–54575 High School and Beyond 2021 Base-Year Full-Scale Intent To Suspend Certain Pesticide Registrations, 54563– Study Data Collection, 54542–54543 54572 Protection and Advocacy of Individual Rights Program Pesticide Registration Review: Assurances, 54538 Draft Human Health and/or Ecological Risk Assessments Study of Financial Aid Supports for GEAR UP Students, for Several Pesticides, 54562–54563 54543–54544 Draft Human Health and/or Ecological Risk Assessments Applications for New Awards: for Strychnine, 54560–54562 Education Research and Special Education Research Proposed Interim Decisions for Several Pesticides, 54572– Grant Programs; Reopening, 54540 54574 VerDate Sep<11>2014 21:20 Sep 01, 2020 Jkt 250001 PO 00000 Frm 00001 Fmt 4748 Sfmt 4748 E:\FR\FM\02SECN.SGM 02SECN jbell on DSKJLSW7X2PROD with CONTENTS IV Federal Register / Vol. 85, No. 171 / Wednesday, September 2, 2020 / Contents Export-Import Bank Food and Drug Administration NOTICES NOTICES Meetings; Sunshine Act, 54575 Drug Products Not Withdrawn From Sale for Reasons of Safety or Effectiveness: Farm Credit Administration MICRO–K LS (Potassium Chloride) Extended-Release NOTICES Liquid
Load more

Recommended publications
  • The Structural Power of Strong Pharmaceutical Patent Protection in U.S. Foreign Policy
    Loyola University Chicago, School of Law LAW eCommons Faculty Publications & Other Works 2003 The trS uctural Power of Strong Pharmaceutical Patent Protection in U.S. Foreign Policy James T. Gathii Loyola University Chicago, School of Law, [email protected] Follow this and additional works at: http://lawecommons.luc.edu/facpubs Part of the Intellectual Property Law Commons, and the International Law Commons Recommended Citation James T. Gathii, The trS uctural Power of Strong Pharmaceutical Patent Protection in U.S. Foreign Policy, 7 J. Gender Race & Just. 267 (2003). This Article is brought to you for free and open access by LAW eCommons. It has been accepted for inclusion in Faculty Publications & Other Works by an authorized administrator of LAW eCommons. For more information, please contact [email protected]. The Structural Power of Strong Pharmaceutical Patent Protection in U.S. Foreign Policy James Thuo Gathii* While the Chief Justice's dissent says there are 'weapons [such as cartels or boycotts] in the arsenalsofforeign nations' sufficient to enable them to counter anticompetitive conduct ... such ... political remed[ies are] hardly available to a foreign nation faced with the monopolistic control of the supply of medicines needed for the health and safety of its people. I I. INTRODUCTION There are two distinct, albeit mutually reinforcing, stances within U.S. foreign policy on HIV/AIDS. The first of these stances favors strong international pharmaceutical patent protection, unencumbered by any restrictions, as the best alternative to ensuring availability of drugs to treat those infected with HIV/AIDS. 2 Unlike the first stance that is Assistant Professor, Albany Law School.
    [Show full text]
  • THE CASE of EBOLA by Tara Kirk Sell, MA a Dissertation
    HEALTH POLICY RESPONSES AND NEWS MEDIA COVERAGE OF AN EMERGING OUTBREAK: THE CASE OF EBOLA by Tara Kirk Sell, MA A dissertation submitted to Johns Hopkins University in conformity with the requirements for the degree of Doctor of Philosophy Baltimore, Maryland April 2016 © 2016 Tara Kirk Sell All Rights Reserved Dissertation Abstract The Ebola outbreak of 2014-2015 and the resulting media and policy responses provide an important case for studying dreaded communicable diseases and other public health emergencies that will test public health policy development and emergency communication. This research examined public health response policies to the Ebola outbreak as well as media messages about these policies and risks from Ebola. Federal guidance and state policies determining how to manage individuals within the U.S. who may have been exposed to Ebola were systematically identified and analyzed. In addition, the volume of news coverage and content of U.S.-focused news stories about Ebola was analyzed for risk-related messages that were judged to potentially increase or decrease perception of risk and policy-related messages about the Ebola response. Policies on quarantine, movement restrictions, exposure categories, and monitoring varied. A number of states enacted more aggressive policies than were called for in guidance from the Centers for Disease Control and Prevention (CDC). Examination of news coverage showed that the volume of stories about Ebola rapidly increased following diagnosis of the Ebola case in Dallas in September 2014. Furthermore, all policy-related messages studied showed significant increases in frequency after this date, with the exception of messages related to isolation, which showed a significant decrease.
    [Show full text]
  • The Work of Military Forces in the Context of the Crisis
    The work of military forces in the context of the COVID-19 crisis Nº2 | July 2020 The work of military forces in the context of COVID-19 crisis • On March 11, 2020, the World Health Organization declared the new coronavirus SARS-CoV-2 outbreak a pandemic. By then, the virus was already spreading worldwide and had turned into a global problem. It was precisely the close connection between countries in a globalized world that caused an impact on so many people, across all continents, in such a short time. Against this backdrop, as was already pointed out in the previous Newsletter, the armed forces were called upon to play a role in response to the crisis. The exponential spread of the disease has led to the implementation of risk management systems in various countries and, in many cases, the armed forces have been deployed due to their quick response and logistic support capabilities. This same situation has been evident in various regions of the world, where the armed forces have been involved in supporting systems, delivering food to people and patrolling areas, among other actions. In this context, it is worth reflecting on their role, particularly the capabilities required for them in order to deal with these types of scenarios and, above all, on the importance of coordination, both at national and international levels. The information below describes the scenarios observed in various parts of the world and depicts some contrasting cases, including Argentina, Bolivia, Brazil, Burkina Faso, Chad, Chile, Colombia, Costa Rica, the Dominican Republic, Ecuador, El Salvador, France, Guatemala, Honduras, Mali, Mexico, Niger, Nigeria, Panama, Paraguay, Peru, Portugal, Spain, the United Kingdom, Uruguay, and Venezuela.
    [Show full text]
  • “Executive Orders” by Tom Clancy
    Sabine Weishaupt, 8B Book-report: “Executive Orders” by Tom Clancy About the Author: Thomas L. Clancy, the so called master of techno-military thrillers, was born on the 12th of April 1947 in Baltimore, Maryland / USA. He was educated at the Loyola College in Baltimore. Then he worked as an insurance broker. He is now living in his second marriage after his divorce in 1998. With his first wife he has four children. In college he dreamed of writing novels. In 1984 this dream came true and he got his first novel published, namely “The Hunt for Red October”, which was a great success. Other also well-known works followed, e.g. “Red Storm Rising” (1986), “Cardinal of the Kremlin” (1988), “Debt of Honor” (1994), “Executive Orders”(1996), “Rainbow Six” (1998) and “The Red Rabbit” (2002). Almost each of his books has been a number one best-seller. “Executive Orders” is part of the so called “Ryanverse collection” that means that in all of these books the main character is Jack Ryan or that the other characters have something to do with him. Clancy has also worked with other authors, e.g. with Steve Pieczenik to create the mini-series “OP-Centre” in 1994. All of his stories deal with military, warfare, intelligence, politics and terrorism. Tom Clancy also wrote non-fiction books about submarines, cavalry, the US Air Force and about the Marine and Airborne corps of the US Army. Four of his novels, namely “The Hunt for Red October”, “Patriot Games”, “Clear and present Danger” and “Sum of all Fears”, have been made into quite successful movies.
    [Show full text]
  • Federal Register/Vol. 77, No. 28/Friday, February 10, 2012
    Federal Register / Vol. 77, No. 28 / Friday, February 10, 2012 / Proposed Rules 7109 ADDRESSES: You may submit comments, DEPARTMENT OF HEALTH AND ADDRESSES: You may submit comments, identified by RIN 1250–AA02, by any of HUMAN SERVICES identified by ‘‘RIN 0920–AA47’’: By any the following methods: of the following methods: 42 CFR Part 71 • Federal eRulemaking Portal: • Internet: Access the Federal e- www.regulations.gov. Follow the [Docket No. CDC–2012–0002] rulemaking portal at http:// instructions for submitting comments. RIN 0920–AA47 www.regulations.gov. Follow the instructions for submitting comments. • Fax: (202) 693–1304 (for comments of six pages or less). Establishment of User Fees for • Mail: Division of Global Migration Filovirus Testing of Nonhuman Primate and Quarantine, Centers for Disease • Mail: Debra A. Carr, Director, Liver Samples Control and Prevention, 1600 Clifton Division of Policy, Planning, and Road NE., MS–03, Atlanta, Georgia AGENCY: Centers for Disease Control and Program Development, Office of Federal 30333, ATTN: NHP NPRM. Contract Compliance Programs, Room Prevention (CDC), Department of Health C–3325, 200 Constitution Avenue NW., and Human Services (HHS). Instructions: All submissions received Washington, DC 20210. ACTION: Notice of Proposed Rulemaking must include the agency name and and request for comments. docket number or Regulation Identifier FOR FURTHER INFORMATION CONTACT: Number (RIN) for this rulemaking. All Debra A. Carr, Director, Division of SUMMARY: Through this Notice of comments will be posted without Policy, Planning and Program Proposed Rulemaking (NPRM), the change to http://regulations.gov, Development, Office of Federal Contract Centers for Disease Control and including any personal information Compliance Programs, 200 Constitution Prevention (CDC), located within the provided.
    [Show full text]
  • Democratic Republic of Congo: Background and U.S. Relations
    Democratic Republic of Congo: Background and U.S. Relations Updated April 30, 2019 Congressional Research Service https://crsreports.congress.gov R43166 Democratic Republic of Congo: Background and U.S. Relations Summary The United States and other donors have focused substantial resources on stabilizing the Democratic Republic of Congo (DRC) since the early 2000s, when “Africa’s World War”—a conflict that drew in multiple neighboring countries and reportedly caused millions of deaths— drew to a close. DRC hosts the world’s largest U.N. peacekeeping operation and is a major recipient of donor aid. Conflict has nonetheless persisted in eastern DRC, prolonging instability and an enduring humanitarian crisis in Africa’s Great Lakes region. New unrest erupted as elections were repeatedly delayed past 2016, their scheduled date, leaving widely unpopular President Joseph Kabila in office. Security forces brutally cracked down on protests, while new conflicts emerged in previously stable regions, possibly fueled by political interference. An ongoing Ebola outbreak in the east has added to DRC’s challenges. In April 2019, the Islamic State organization claimed responsibility for an attack on local soldiers in the Ebola-affected area, an apparent effort to rebrand a local armed group known as the Allied Democratic Forces. National elections were ultimately held on December 30, 2018, following intense domestic and regional pressure. Opposition figure Felix Tshisekedi unexpectedly won the presidential contest, though his ability to assert a popular mandate may be undermined by allegations that the official results were rigged to deny victory to a more hardline opposition rival. Many Congolese nonetheless reacted to the outcome with relief and/or enthusiasm, noting that Kabila would step down and that voters had soundly defeated his stated choice of successor, a former Interior Minister.
    [Show full text]
  • Overview of Executive Actions Signed by President Joseph Biden Total
    Overview of Executive Actions Signed by President Joseph Biden Total Number of Executive Actions Signed as of March 12: 57 Subject Executive Action Total Executive Order on Protecting the Federal Workforce Economy Executive Order on Economic Relief Related to the COVID-19 Pandemic 3 Pausing Federal Student Loan Payments Memorandum on Maximizing Assistance from the Federal Emergency Management Agency Proclamation on the Suspension of Entry as Immigrants and Non-Immigrants of Certain Additional Persons Who Pose a Risk of Transmitting Coronavirus Disease Executive Order on Establishing the COVID-19 Pandemic Testing Board and Ensuring a Sustainable Public Health Workforce for COVID-19 and Other Biological Threats National Security Directive on United States Global Leadership to Strengthen the International COVID-19 Response and to Coronavirus Advance Global Health Security and Biological Preparedness 15 Executive Order on Protecting Worker Health and Safety Executive Order on Supporting the Reopening and Continuing Operation of Schools and Early Childhood Education Providers Executive Order on Ensuring an Equitable Pandemic Response and Recovery Executive Order on a Sustainable Public Health Supply Chain 3/12/2021 Subject Executive Action Total Memorandum to Extend Federal Support to Governors’ Use of the National Guard to Respond to COVID-19 and to Increase Reimbursement and Other Assistance Provided to States Executive Order on Ensuring a Data-Driven Response to COVID-19 and Future High-Consequence Public Health Threats Executive Order
    [Show full text]
  • Edicine SPECIAL ISSUE FALL 2014
    edicine SPECIAL ISSUE FALL 2014 We live in a world where we are all connected by the air we breathe, the water we drink, the food we eat, and by airplanes that can bring disease from anywhere to anywhere in a day. — CDC Director Tom Frieden We can fear, or we can care. —Emory Healthcare Chief Nurse Executive Susan Grant 2 EMORY MEDICINE AUG. 21, 2014 - Medical missionary Kent Brantly beams as he leaves Emory’s isolation unit, thanking the medical team who cared for him during his recovery from Ebola virus. 8 Fall 2014 3 edicine WINTER 2014 THESEEING EYE DRUG DISCOVERY REVISITED FOUR QUESTIONS TO ASK ABOUT THE HEALTH CARE LAW STOPPING INTIMATE PARTNER VIOLENCE TOP 10 NATIONAL QUALITY RANKINGS ONLINE PORTAL FOR Hitting stroke hardCANCER ANSWERS The best care includes compassion DAVID JACOBS MAKES A COMEBACK In August, two American missionaries who contracted Ebola while working in a Liberian hospital—Dr. Kent Brantly and Ms. Nancy Writebol—were flown back to Download our iPad app, search Emory Health. the US to be cared for at Emory University For bonus multimedia features online, visit Hospital. Our entire team, under the leader- emorymedicinemagazine.emory.edu. ship of Dr. Bruce Ribner, worked around the clock preparing the hospital’s special isolation unit for the country’s first Ebola Emory Medicine John Fox patients. We knew we could provide a Editor Mary Loftus President & CEO Emory Healthcare high level of care that would improve their Art Director Peta Westmaas Christian Larsen chances for a positive outcome and that we Director of Photography Jack Kearse Graphic Designer Linda Dobson Dean, Emory School of Medicine could do it safely, in a manner that would VP for Health Center Integration Production Manager Carol Pinto protect others.
    [Show full text]
  • Federal Register/Vol. 79, No. 205/Thursday, October 23, 2014
    63314 Federal Register / Vol. 79, No. 205 / Thursday, October 23, 2014 / Rules and Regulations current Ebola virus disease (Ebola) This list of affected countries and Fischer, Bridge Administrator, epidemic is the largest in history, airports may be modified by an updated Thirteenth District, Coast Guard; affecting multiple countries in West publication in the Federal Register or telephone 206–220–7282, email Africa. Ebola, previously known as by posting an advisory to follow at [email protected]. If you Ebola hemorrhagic fever, is a rare and www.cbp.gov. The restrictions will have questions on viewing the docket, deadly disease caused by infection with remain in effect until superseded, call Cheryl Collins, Program Manager, one of the Ebola virus strains. Ebola can modified, or revoked by publication in Docket Operations, telephone 202–366– cause disease in humans, nonhuman the Federal Register or posting on 9826. primates (monkeys, gorillas, and www.cbp.gov. SUPPLEMENTARY INFORMATION: The chimpanzees), and other animals. Ebola Dated: October 21, 2014. is caused by infection with a virus of the Washington State Department of R. Gil Kerlikowske, family Filoviridae, genus Ebolavirus. Transportation, on behalf of the There are five identified Ebola virus Commissioner. University of Washington Police species found in several African [FR Doc. 2014–25358 Filed 10–21–14; 4:15 pm] Department, has requested that the countries. The current outbreak is due BILLING CODE 9111–14–P Evergreen Point Floating Bridge (State to Ebola virus (Zaire ebolavirus) in Route 520) remain closed to vessel Guinea, Sierra Leone, and Liberia. traffic, and need not open to vessel In order to assist in preventing the DEPARTMENT OF HOMELAND traffic to facilitate timely movement of further introduction and spread of this SECURITY pre-game and post-game football traffic.
    [Show full text]
  • Vol. 86 Thursday, No. 4 January 7, 2021 Pages 933–1248
    Vol. 86 Thursday, No. 4 January 7, 2021 Pages 933–1248 OFFICE OF THE FEDERAL REGISTER VerDate Sep 11 2014 21:11 Jan 06, 2021 Jkt 253001 PO 00000 Frm 00001 Fmt 4710 Sfmt 4710 E:\FR\FM\07JAWS.LOC 07JAWS jbell on DSKJLSW7X2PROD with FR_WS II Federal Register / Vol. 86, No. 4 / Thursday, January 7, 2021 The FEDERAL REGISTER (ISSN 0097–6326) is published daily, SUBSCRIPTIONS AND COPIES Monday through Friday, except official holidays, by the Office PUBLIC of the Federal Register, National Archives and Records Administration, under the Federal Register Act (44 U.S.C. Ch. 15) Subscriptions: and the regulations of the Administrative Committee of the Federal Paper or fiche 202–512–1800 Register (1 CFR Ch. I). The Superintendent of Documents, U.S. Assistance with public subscriptions 202–512–1806 Government Publishing Office, is the exclusive distributor of the official edition. Periodicals postage is paid at Washington, DC. General online information 202–512–1530; 1–888–293–6498 Single copies/back copies: The FEDERAL REGISTER provides a uniform system for making available to the public regulations and legal notices issued by Paper or fiche 202–512–1800 Federal agencies. These include Presidential proclamations and Assistance with public single copies 1–866–512–1800 Executive Orders, Federal agency documents having general (Toll-Free) applicability and legal effect, documents required to be published FEDERAL AGENCIES by act of Congress, and other Federal agency documents of public Subscriptions: interest. Assistance with Federal agency subscriptions: Documents are on file for public inspection in the Office of the Federal Register the day before they are published, unless the Email [email protected] issuing agency requests earlier filing.
    [Show full text]
  • Can the President Bar Foreign Travelers from Ebola-Stricken Countries from Entering the United States?
    Legal Sidebar Can the President Bar Foreign Travelers from Ebola-Stricken Countries from Entering the United States? 10/23/2014 The recent outbreak of the Ebola virus in West Africa has prompted concern over the risk that foreign travelers may carry the virus to the United States -- a concern that has grown since an infected Liberian national who traveled to the United States infected two nurses who cared for him at a Dallas hospital. On Monday, October 21, the Department of Homeland Security announced new screening procedures at U.S. ports of entry for travelers from Ebola-stricken countries in West Africa. Several Members of Congress have gone further and suggested a blanket ban on the admission into the United States of foreign nationals who reside in or have recently traveled to Ebola-stricken countries – a suggestion that the Obama Administration has thus far opposed. Although it has never been used for such purposes, section 212(f) of the Immigration and Nationality Act (INA) seems to confer the President with authority to bar foreign travelers from Ebola- stricken countries from entering the United States, if he deems such a restriction necessary to protect U.S. interests, regardless of whether there is a reason to believe that a particular traveler is infected with the Ebola virus. Foreign nationals do not have a constitutional right to be admitted into the United States, and rules governing whether and when such persons may be admitted are contained in the INA. The INA establishes several grounds under which an alien may be rendered ineligible to obtain a visa to come to the United States or otherwise be admitted into the country.
    [Show full text]
  • Emergency Legal Preparedness and FDA Response to Zika Virus
    Emergency Legal Preparedness and FDA Response to Zika Virus ABA Washington Health Summit December 12, 2016 Brooke Courtney, JD, MPH Senior Regulatory Counsel Office of Counterterrorism and Emerging Threats Office of the Commissioner Counterterrorism and Emerging Threats • Protecting the U.S. from threats . Chemical, biological, radiological, nuclear (CBRN) . Emerging infectious diseases • Ensuring that medical countermeasures (MCMs) to counter these threats are safe, effective, and secure . Drugs, vaccines, devices (e.g., diagnostic tests, personal protective equipment (PPE)) • Office of Counterterrorism and Emerging Threats . Facilitate the development and availability of safe, effective MCMs . Serve as point of entry on policy and planning for global health security, counterterrorism, emerging threats . Identify and resolve complex scientific and regulatory challenges for MCMs within FDA and with USG partners www.fda.gov Overview of Public Health Legal Preparedness Public Health Legal Preparedness • Term first appeared in late 1990s; subset of public health preparedness • Recognizes essential role law plays in protecting the public from catastrophic health events . Core foundation to ensure U.S. is prepared to prevent, respond to, and reduce adverse effects of public health emergencies • May impact a range of players during disasters . e.g.) health officials, hospitals, health care practitioners, businesses, MCM manufacturers, public, etc. Moulton et al. Journal of Law, Medicine & Ethics. 2003;31; The National Action Agenda for Public Health Legal Preparedness. Journal of Law, Medicine & Ethics. 2008;36(1). Levels (and Layers) of Authority • Global . WHO (Director-General) (e.g., IHR, PHEIC declaration) . Individual countries (substantial variation in laws, capabilities, declarations) • Federal (e.g., President, Cabinet Secretaries) . e.g.) emergency laws, declarations • State (e.g., Governor, Secretary of Health) .
    [Show full text]