Last data update: May 06, 2024. (Total: 46732 publications since 2009)
Records 1-3 (of 3 Records) |
Query Trace: Hemphill M[original query] |
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Review of restricted experiment requests, division of select agents and toxins, US Centers for Disease Control and Prevention, 2014-2021
Smith J , Gangadharan D , Hemphill M , Edwin S . Health Secur 2023 21 (3) 207-213 The US Centers for Disease Control and Prevention Division of Select Agents and Toxins (DSAT) regulates laboratories that possess, use, or transfer select agents and toxins within United States as part of the Federal Select Agent Program. DSAT also mitigates biosafety risks through the review of "restricted experiments," which under the select agent regulations are experiments that pose heightened biosafety risks. In a previous study, we evaluated restricted experimental requests submitted to DSAT for review between 2006 and 2013. The purpose of this study is to provide an updated analysis of requests to conduct potential restricted experiments submitted to DSAT between 2014 and 2021. This article describes the trends and characteristics of the data associated with restricted experimental requests involving select agents and toxins that have an impact on public health and safety (US Department of Health and Human Services agents only) or both public health and safety and animal health or products (overlap agents). From January 2014 to December 2021, DSAT received 113 requests to conduct potential restricted experiments; however, 82% (n=93) of those requests were determined not to meet the regulatory definition of a restricted experiment. Of the 20 requests that met the definition of a restricted experiment, 8 were denied because the experiments had the potential to compromise disease control in humans. DSAT continues to encourage entities to practice due diligence and request a review of research that could potentially meet the regulatory definition of a restricted experiment out of an abundance of caution to protect public health and safety and prevent any potential compliance action. |
Review of requests to exclude attenuated strains of select agents and modified select toxins, Division of Select Agents and Toxins, Centers for Disease Control and Prevention, 2003-2017
Smith J , Gangadharan D , Hemphill M , Edwin S . Health Secur 2018 The Centers for Disease Control and Prevention's Division of Select Agents and Toxins (DSAT) regulates the possession, use, and transfer of select agents and toxins throughout the United States as part of the Federal Select Agent Program. The Department of Health and Human Services (HHS) select agent regulations also include criteria for the exclusion of select agents and toxins from the requirements of the regulations (42 CFR section sign 73.3 and 73.4). An entity may request the exclusion of an attenuated strain of a select agent or a select toxin modified to be less potent or toxic. The Intragovernmental Select Agents and Toxins Technical Advisory Committee (ISATTAC) reviews the exclusion request by conducting a risk assessment to determine whether the attenuated strain or modified toxin has the potential to pose a severe risk to public health and safety. In this study, DSAT analyzed the number and types of exclusion requests reviewed by the ISATTAC from January 2003 through December 2017. As of December 2017, DSAT has excluded 50 strains of biological agents and 10 modified toxins from the select agent regulations. The select agent regulations provision for the exclusion of attenuated select agents or modified toxins that no longer have the potential to pose a severe threat to public health and safety is an important mechanism for reducing the regulatory burden on entities that do not need to work with the fully virulent or toxic forms of the agent or toxin. This provision may have the added benefit of encouraging entities to consider working with variants of select agents or toxins that are of less risk than the fully virulent or toxic forms in their research studies and as a positive control. |
Surveillance for traumatic brain injury-related deaths--United States, 1997-2007
Coronado VG , Xu L , Basavaraju SV , McGuire LC , Wald MM , Faul MD , Guzman BR , Hemphill JD . MMWR Surveill Summ 2011 60 (5) 1-32 PROBLEM/CONDITION: Traumatic brain injury (TBI) is a leading cause of death and disability in the United States. Approximately 53,000 persons die from TBI-related injuries annually. During 1989-1998, TBI-related death rates decreased 11.4%, from 21.9 to 19.4 per 100,000 population. This report describes the epidemiology and annual rates of TBI-related deaths during 1997-2007. REPORTING PERIOD: January 1, 1997-December 31, 2007. DESCRIPTION OF SYSTEM: Data were analyzed from the CDC multiple-cause-of-death public-use data files, which contain death certificate data from all 50 states and the District of Columbia. RESULTS: During 1997-2007, an annual average of 53,014 deaths (18.4 per 100,000 population; range: 17.8-19.3) among U.S. residents were associated with TBIs. During this period, death rates decreased 8.2%, from 19.3 to 17.8 per 100,000 population (p = 0.001). TBI-related death rates decreased significantly among persons aged 0-44 years and increased significantly among those aged ≥75 years. The rate of TBI deaths was three times higher among males (28.8 per 100,000 population) than among females (9.1). Among males, rates were highest among non-Hispanic American Indian/Alaska Natives (41.3 per 100,000 population) and lowest among Hispanics (22.7). Firearm- (34.8%), motor-vehicle- (31.4%), and fall-related TBIs (16.7%) were the leading causes of TBI-related death. Firearm-related death rates were highest among persons aged 15-34 years (8.5 per 100,000 population) and ≥75 years (10.5). Motor vehicle-related death rates were highest among those aged 15-24 years (11.9 per 100,000 population). Fall-related death rates were highest among adults aged ≥75 years (29.8 per 100,000 population). Overall, the rates for all causes except falls decreased. INTERPRETATION: Although the overall rate of TBI-related deaths decreased during 1997-2007, TBI remains a public health problem; approximately 580,000 persons died with TBI-related diagnoses during this reporting period in the United States. Rates of TBI-related deaths were higher among young and older adults and certain minority populations. The leading external causes of this condition were incidents related to firearms, motor vehicle traffic, and falls. PUBLIC HEALTH ACTIONS: Accurate, timely, and comprehensive surveillance data are necessary to better understand and prevent TBI-related deaths in the United States. CDC multiple-cause-of-death public-use data files can be used to monitor the incidence of TBI-related deaths and assist public health practitioners and partners in the development, implementation, and evaluation of programs and policies to reduce and prevent TBI-related deaths in the United States. Rates of TBI-related deaths are higher in certain population groups and are primarily related to specific external causes. Better enforcement of existing seat belt laws, implementation and increased coverage of more stringent helmet laws, and the implementation of existing evidence-based fall-related prevention interventions are examples of interventions that can reduce the incidence of TBI in the United States. |
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