DOCSLIB.ORG

Federal Register/Vol. 77, No. 28/Friday, February 10, 2012

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read 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. For detailed instructions on Avenue NW., Room C–3325, Department of Health and Human submitting comments and additional Washington, DC 20210. Telephone: Services (HHS) is proposing to establish information on the rulemaking process, (202) 693–0103 (voice) or (202) 693– a user fee for filovirus testing of all see the ‘‘Public Participation’’ heading 1337 (TTY). nonhuman primates that die during the of the SUPPLEMENTARY INFORMATION HHS/CDC-required 31-day quarantine section of this document. SUPPLEMENTARY INFORMATION: On period for any reason other than trauma. Docket: For access to the docket to December 9, 2011, OFCCP published a We propose to establish a filovirus read background documents or proposed rule entitled, ‘‘Affirmative testing service at HHS/CDC because comments received, please go to Action and Nondiscrimination testing is no longer being offered by the http://www.regulations.gov. Comments Obligations of Contractors and only private, commercial laboratory that will be available for public inspection Subcontractors Regarding Individuals previously performed these tests. This Monday through Friday, except for legal with Disabilities’’ (76 FR 77056). OFCCP testing service will be funded through holidays, from 9 a.m. until 5 p.m., was to receive comments on this NPRM user fees. Elsewhere in this issue of the Eastern Time, at 1600 Clifton Road NE., Federal Register, HHS/CDC is on or before February 7, 2012. Atlanta, Georgia 30333. Please call simultaneously publishing a companion Various organizations and entities ahead to 1–866–694–4867 and ask for a direct final rule that proposes identical submitted requests to extend the representative in the Division of Global filovirus testing and user fee comment period by an additional 90 Migration and Quarantine (DGMQ) to requirements in this Federal Register days or more. We considered these schedule your visit. To download an because it believes that these requests and determined that it is electronic version of the rule, access requirements are non-controversial and appropriate to provide an additional 14- http://www.regulations.gov. unlikely to generate significant adverse day period for comment on the comment. If HHS/CDC does not receive FOR FURTHER INFORMATION CONTACT: For proposed regulation. We are, therefore, any significant adverse comment on the questions concerning this notice of extending the comment period until, direct final rule within the specified proposed rulemaking: Ashley A. Tuesday, February 21, 2012. comment period, it will publish a notice Marrone, JD, Centers for Disease Control Extension of Comment Period: OFCCP in the Federal Register withdrawing and Prevention, 1600 Clifton Road NE., determined that the public could use this notice of proposed rulemaking and Mailstop E–03, Atlanta, Georgia 30333; additional time to review the potential confirming the effective date of the telephone 404 498–1600. For impact of the proposed requirements. direct final rule within 30 days after the information concerning program Therefore, to allow the public sufficient end of the comment period on the direct operations: Dr. Robert Mullan, Centers time to review and comment on the final rule. If HHS/CDC receives any for Disease Control and Prevention, NPRM, OFCCP is extending the timely significant adverse comment, it 1600 Clifton Road NE., Mailstop E–03, comment period until February 21, will withdraw the direct final rule in Atlanta, Georgia 30333; telephone 404 2012. part or in whole by publication of a 498–1600. notice in the Federal Register within 30 SUPPLEMENTARY INFORMATION: This Signed at Washington, DC, this 6th day of days after the comment period ends and preamble is organized as follows: February, 2012. proceed with notice and comment Patricia A. Shiu, under this notice of proposed I. Public Participation Director, Office of Federal Contract rulemaking. A significant adverse II. Background Compliance Programs. comment is one that explains: Why the III. Rationale for Proposal IV. User Fee [FR Doc. 2012–3106 Filed 2–7–12; 11:15 am] direct final rule is inappropriate, V. Services and Activities Covered by This BILLING CODE 4510–45–P including challenges to the rule’s underlying premise or approach; or why User Fees VI. Analysis of User Fee Charge (Cost to the direct final rule will be ineffective Government) or unacceptable without a change. VII. Payment Instructions DATES: Submit written or electronic VIII. Regulatory Analysis comments by April 10, 2012. IX. References VerDate Mar<15>2010 20:17 Feb 09, 2012 Jkt 226001 PO 00000 Frm 00105 Fmt 4702 Sfmt 4702 E:\FR\FM\10FEP1.SGM 10FEP1 mstockstill on DSK4VPTVN1PROD with PROPOSALS 7110 Federal Register / Vol. 77, No. 28 / Friday, February 10, 2012 / Proposed Rules I. Public Participation occur, with hemorrhagic manifestations development of improved laboratory Interested persons are invited to ranging from petechiae to frank tests. As indicated in the 1990 notice, participate in this rulemaking by bleeding. Death occurs primarily as a importers were informed of these submitting written views, opinions, result of multi-organ failures. There is changes by letter from HHS/CDC (6). recommendations, and data. Comments no specific therapy, and patient The current special-permit notice received, including attachments and management is usually limited to requires filovirus antigen-detection other supporting materials, are part of supportive measures. The disease in testing on liver specimens from any the public record and subject to public nonhuman primates is very similar to NHP that dies during quarantine for that in humans, with a very high reasons other than trauma (7, 8). disclosure. Do not include any mortality. Antibody testing is also required on information in your comment or On January 19, 1990, in response to surviving NHPs that exhibit signs of supporting materials that you do not the identification of Ebola-Reston virus possible filovirus infection before the wish to be disclosed publicly. in NHPs imported from the Philippines, cohort is released from quarantine (9). Comments are invited on any topic HHS/CDC published interim guidelines Since October 10, 1975, HHS/CDC has directly related to this proposed rule. for handling NHPs during transit and prohibited the importation of NHPs II. Background also during quarantine (1). Importers of except for scientific, educational, or NHPs were informed by letter from the exhibition purposes. Over time, various Filoviruses belong to a family of HHS/CDC Director on March 15, 1990, measures (e.g., reports, letters, viruses known to cause severe that they must comply with specific guidelines, notices), have been used to hemorrhagic fever in humans and isolation and quarantine standards support implementation of these nonhuman primates (NHPs). So far, only under 42 CFR part 71 for continued regulations. On January 5, 2011, HHS/ two members of this virus family have registration as an importer of NHPs (2). CDC posted a Notice of Proposed been identified: Ebola virus and On March 23, 1990, HHS/CDC held a Rulemaking (NPRM) to begin the Marburg virus. Five species of Ebola meeting at CDC headquarters in Atlanta, process of revising these requirements. virus have been acknowledged: Zaire, Georgia, at which the public could The NPRM was intended to solicit Sudan, Reston, Ivory Coast, and comment on new guidelines for the public comment and feedback on the Bundibugyo. Most strains of Ebola virus importation of NHPs and the potential issue of NHP importation to determine can be highly fatal in humans, and impact of a temporary ban on the the need for further rulemaking. Please while the Reston strain is the only strain importation of cynomolgus
Load more

Recommended publications
  • 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.
    [Show full text]
  • 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]
  • 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]