Last data update: May 06, 2024. (Total: 46732 publications since 2009)
Records 1-5 (of 5 Records) |
Query Trace: Weyant R[original query] |
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Transfer of Select Agents and Toxins: 2003-2013
Shelby BD , Cartagena D , McClee V , Gangadharan D , Weyant R . Health Secur 2015 13 (4) 256-66 The Federal Select Agent Program, which is composed of the Centers for Disease Control and Prevention Division of Select Agents and Toxins and the Animal and Plant Health Inspection Service Agricultural Select Agent Services, regulates entities that possess, use, or transfer biological select agents and toxins in the United States and must preapprove all transfers within or into the US. The requirement to preapprove transfers allows the Federal Select Agent Program to monitor and track shipments to receive alerts of theft, loss, or release during shipment, thereby protecting public health and safety. As part of the program, the Division of Select Agents and Toxins regulates biological select agents and toxins that have been identified by the US government as posing a severe threat to public health and safety. The division analyzed 4,402 transfers that occurred between March 2003 and December 2013 to identify frequently transferred biological select agents and toxins and the types of entities involved in transfers. During the study period, 1 package was lost during shipment and it was determined not to pose a threat to public health. The Federal Bureau of Investigation investigated the loss and concluded that the package was most likely damaged by the commercial carrier and discarded. Further, there were no reports of theft or release associated with biological select agents and toxins shipments. This report represents the first in-depth review of biological select agent and toxin transfers that were approved by the Division of Select Agents and Toxins. |
Review of Restricted Experiment Requests, Division of Select Agents and Toxins, Centers for Disease Control and Prevention, 2006-2013
Smith J , Gangadharan D , Weyant R . Health Secur 2015 13 (5) 307-16 The Centers for Disease Control and Prevention (CDC) Division of Select Agents and Toxins (DSAT) regulates laboratories that possess, use, or transfer select agents and toxins in the United States. DSAT also mitigates biosafety risks through the review of "restricted experiments," which under the select agent regulations are experiments that pose heightened biosafety risks. From January 2006 through December 2013, DSAT received 618 requests from 109 entities to perform potentially restricted experiments. Of these requests, 85% were determined not to meet the regulatory definition of a restricted experiment, while 15% of the requests met the definition of a restricted experiment. Of the 91 restricted experiments proposed, DSAT approved 31 (34%) requests because the biosafety conditions proposed were commensurate with the experiments' biosafety risk. All 31 approved restricted experiments were for work with select toxins. DSAT did not approve 60 restricted experiment requests due to potentially serious biosafety risks to public health and safety. All 60 denied restricted experiments proposed inserting drug resistance traits into select agents that could compromise the control of disease. The select agents and toxins associated most frequently with requests that met the regulatory definition of a restricted experiment are Shiga toxin (n = 16), Burkholderia mallei (n = 15), Botulinum neurotoxin (n = 14), and Brucella abortus (n = 14). In general, all restricted experiment decisions are determined on a case-by-case basis. This article describes the trends and characteristics of the data associated with restricted experiment requests among select agents that have an impact on public health and safety (HHS only agents) or both public health and safety and animal health or products (overlap agents). The information presented here, coupled with the information published in the restricted experiment guidance document ( www.selectagents.gov ), is intended to promote awareness among the research community of the type of experiments that meet the regulatory definition of a restricted experiment as well as to provide a greater understanding of the restricted experiment review process. |
The impact of HIV care and support interventions on key outcomes in low- and middle-income countries: a literature review - introduction
Kaplan JE , Hamm TE , Forhan S , Saadani Hassani A , Bang G , Weyant E , Tchuenche M , Langley C , Lapidos-Salaiz I , Bateganya MH . J Acquir Immune Defic Syndr 2015 68 Suppl 3 S253-6 As of December 2012, an estimated 35.3 million persons were living with HIV; approximately two thirds of these people were living in sub-Saharan Africa.1 The response to the HIV pandemic in Africa and in other low-and middle-income regions of the world has consisted of a variety of bilateral and multi-lateral support from donor agencies, as well as local support from countries that have been able to afford it. A majority of the support has been directed towards HIV care and treatment. | Accordingly, the past ten years have witnessed a remarkable increase in the number of HIV-infected persons receiving antiretroviral therapy (ART) in low- and middle-income countries--from 300,000 in 2003 to 9.7 million in 20121,2. Expanded access to ART in these countries has led to significant proportions of eligible persons enrolled on ART, reaching coverage rates as high as 61% based on the World Health Organization (WHO) treatment guidelines eligibility criteria of CD4 <350 cells/uL) in 2012.1 In 2013, WHO revised its guidelines to indicate eligibility at CD4 <500 cells/uL; under these criteria, only 34% of eligible persons were on ART in 2013.1 Nevertheless, these changes in access to ART were estimated to have averted 4.2 million deaths through 20122.1 | HIV treatment programs in low- and middle-income countries have been supported by a variety of sources, including over $50 billion through the U.S. President's Emergency Plan for AIDS Relief (PEPFAR) from 2004 to 20133. PEPFAR programs are coordinated by the U.S. Department of State’s Office of the U.S. Global AIDS Coordinator (OGAC) in Washington, D.C.,; oversight of in-country expenditures is supported by additional U.S. government(USG) agencies with the majority of funds concentrated in 36 countries and regions 4 in sub-Saharan Africa, South and Central Asia, Eastern Europe, Central America and the Caribbean. PEPFAR supports a range of HIV care and treatment services besides ART including clinical (e.g. monitoring to determine eligibility for ART and prevention and treatment of opportunistic infections) and non-clinical services (e.g. psychological, social, and preventive)4. Services implemented through PEPFAR support in each country are determined through a dialogue between the USG, and host governments. PEPFAR country operating plans and budgets are submitted annually and reviewed by USG staff. |
Topical fluoride for caries prevention: executive summary of the updated clinical recommendations and supporting systematic review
Weyant RJ , Tracy SL , Anselmo TT , Beltran-Aguilar ED , Donly KJ , Frese WA , Hujoel PP , Iafolla T , Kohn W , Kumar J , Levy SM , Tinanoff N , Wright JT , Zero D , Aravamudhan K , Frantsve-Hawley J , Meyer DM . J Am Dent Assoc 2013 144 (11) 1279-91 BACKGROUND: A panel of experts convened by the American Dental Association (ADA) Council on Scientific Affairs presents evidence-based clinical recommendations regarding professionally applied and prescription-strength, home-use topical fluoride agents for caries prevention. These recommendations are an update of the 2006 ADA recommendations regarding professionally applied topical fluoride and were developed by using a new process that includes conducting a systematic review of primary studies. TYPES OF STUDIES REVIEWED: The authors conducted a search of MEDLINE and the Cochrane Library for clinical trials of professionally applied and prescription-strength topical fluoride agents-including mouthrinses, varnishes, gels, foams and pastes-with caries increment outcomes published in English through October 2012. RESULTS: The panel included 71 trials from 82 articles in its review and assessed the efficacy of various topical fluoride caries-preventive agents. The panel makes recommendations for further research. PRACTICAL IMPLICATIONS: The panel recommends the following for people at risk of developing dental caries: 2.26 percent fluoride varnish or 1.23 percent fluoride (acidulated phosphate fluoride) gel, or a prescription-strength, home-use 0.05 percent fluoride gel or paste or 0.09 percent fluoride mouthrinse for patients 6 years or older. Only 2.26 percent fluoride varnish is recommended for children younger than 6 years. The strengths of the recommendations for the recommended products varied from "in favor" to "expert opinion for." As part of the evidence-based approach to care, these clinical recommendations should be integrated with the practitioner's professional judgment and the patient's needs and preferences. |
Biosafety Recommendations for Work with Influenza Viruses Containing a Hemagglutinin from the A/goose/Guangdong/1/96 Lineage
Gangadharan D , Smith J , Weyant R . MMWR Recomm Rep 2013 62 1-7 The CDC and National Institutes of Health (NIH) Biosafety in Microbiological and Biomedical Laboratories (BMBL) manual describes biosafety recommendations for work involving highly pathogenic avian influenza (HPAI) (US Department of Health and Human Services [HHS], CDC. Biosafety in microbiological and biomedical laboratories, 5th ed. Atlanta, GA: CDC; 2009. HHS publication no. [CDC] 21-1112. Available at http://www.cdc.gov/biosafety/publications/bmbl5). The U.S. Department of Agriculture Guidelines for Avian Influenza Viruses builds on the BMBL manual and provides additional biosafety and biocontainment guidelines for laboratories working with HPAI (US Department of Agriculture, Animal and Plant Health Inspection Service, Agricultural Select Agent Program. Guidelines for avian influenza viruses. Washington, DC: US Department of Agriculture; 2011. Available at http://www.selectagents.gov/Guidelines_for_Avian_Influenza_Viruses.html). The recommendations in this report, which are intended for laboratories in the United States, outline the essential baseline biosafety measures for working with the subset of influenza viruses that contain a hemagglutinin (HA) from the HPAI influenza A/goose/Guangdong/1/96 lineage, including reassortant influenza viruses created in a laboratory setting. All H5N1 influenza virus clades known to infect humans to date have been derived from this lineage (WHO/OIE/FAO H5N1 Evolution Working Group. Continued evolution of highly pathogenic avian influenza A [H5N1]: updated nomenclature. Influenza Other Respir Viruses 2012;6:1-5). In 2009, the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules were amended to include specific biosafety and biocontainment recommendations for laboratories working with Recombinant Risk Group 3 influenza viruses, including HPAI H5N1 influenza viruses within the Goose/Guangdong/1/96-like H5 lineage. In February 2013, the NIH guidelines were further revised to provide additional biosafety containment enhancements and practices for research with HPAI H5N1 viruses that are transmissible among mammals by respiratory droplets (i.e., mammalian-transmissible HPAI H5N1) (National Institutes of Health, Office of Biotechnology Activities. NIH guidelines for research involving recombinant or synthetic nucleic acid molecules. Appendix G-II-C-5: biosafety level 3 enhanced for research involving risk group 3 influenza viruses. Bethesda, MD: National Institutes of Health; 2013. Available at http://oba.od.nih.gov/rdna/nih_guidelines_oba.html). The recent revisions to the NIH guidelines focus on a smaller subset of viruses but are applicable and consistent with the recommendations in this report. The biosafety recommendations in this report were developed by CDC with advice from the Intragovernmental Select Agents and Toxins Technical Advisory Committee, which is a panel composed of federal government subject-matter experts, and from public input received in response to the request for information that was published in the Federal Register on October 17, 2012 (US Department of Health and Human Services, CDC. Influenza viruses containing the hemagglutinin from the Goose/ Guangdong/1/96 lineage; proposed rule; request for information and comment. 42 CFR, Part 73. Federal Register 2012;77:63783-5). Work with HPAI H5N1 virus should be conducted, at a minimum, at biosafety level 3 (BSL-3), with specific enhancements to protect workers, the public, animal health, and animal products. Original clinical specimens suspected of containing viruses of this lineage can only be handled at BSL-2 if the procedures do not involve the propagation of the virus. An appropriate biosafety level should be determined in accordance with a biosafety risk assessment. Additional information on performing biosafety risk assessments and establishing effective biosafety containment is available in the BMBL manual. |
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