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SUMMARY: The Secretary of Health and Human Services (HHS) is issuing this notice pursuant to section 564(b) of the Federal Food, Drug, and Cosmetic (FD&C) Act, 21 U.S.C. § 360 bbb-3(b)(4). On April 19, 2013, the Secretary determined that there is a significant potential for a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad and that involves the avian influenza A (H7N9) virus.
On the basis of this determination, she also declared that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection of the avian influenza A (H7N9) virus pursuant to section 564(b)(1) of the FD&C Act, 21 U.S.C. § 360 bbb-3(b)(1), subject to the terms of any authorization issued under that section.
Under Section 564 of the FD&C Act, the Commissioner of the Food and Drug Administration (FDA), acting under delegated authority from the Secretary of HHS, may issue an Emergency Use Authorization (EUA):
1) authorizing the emergency use of an unapproved drug, an unapproved or uncleared device, or an unlicensed biological product; or
2) an unapproved use of an approved drug, approved or cleared device, or licensed biological product.
Source (PDF File)
II. Determination by the Secretary of Health and Human Services
On April 19, 2013, pursuant to section 564(b)(1)(C) of the FD&C Act, 21 U.S.C. § 360bbb- 3(b)(1)(C), I determined that there is a significant potential for a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad and that involves the avian influenza A (H7N9) virus.
About In Vitro Diagnostics
In vitro diagnostic (IVD) tests are performed to provide a diagnosis by assessing an analyte in a test tube, or more generally, in a controlled environment outside a living organism. The use of the term 'in vitro', which in Latin means 'in glass', is a reflection of the fact that the vast majority of these tests were originally performed in a test tube. The modern IVD industry produces reagents and analytical instruments, used to perform an array of in vitro tests to diagnose and monitor different types of diseases. The reagent used in an IVD test is a highly specialised chemical or biological substance that is able to react with target substances in the biological samples provided by the patient, which may include blood, tissue, urine or another type of sample. This process provides a result that can be measured or seen, helping doctors to make a health-related assesment.
Meanwhile, the National Health and Family Planning Commission said in its daily update on H7N9 cases that a total of 109 H7N9 cases have been reported within mainland China, including 23 deaths. Most cases have been confined to Shanghai and neighboring provinces in eastern China.
The global mortality rate from the 1918/1919 pandemic is not known, but an estimated 10% to 20% of those who were infected died. With about a third of the world population infected, this case-fatality ratio means 3% to 6% of the entire global population died. Influenza may have killed as many as 25 million people in its first 25 weeks. Older estimates say it killed 40–50 million people, while current estimates say 50–100 million people worldwide were killed.
Originally posted by liveandlearn
I would say it means they can test you without your permission esp. if you have been out of the country and/or the test may not yet be proven. Declaring an emergency would allow this.
This is just a best guess though.
The deadly H7N9 bird flu strain claimed a new victim yesterday when a hospital patient died in China, state media reported, bringing the death toll from the recently identified virus to 24. A patient surnamed Chen died in the eastern city of Shanghai after 12 days of medical treatment failed, Xinhua news agency said. China has recorded more than 120 cases of H7N9 infection so far. Most cases since the new strain was first identified in late March have been confined to eastern China, and the only one reported outside mainland China has been in Taiwan. The Taiwanese victim was infected in China. But experts fear the possibility of the virus mutating into a form easily transmissible between humans, with the potential to trigger a pandemic. The World Health Organization has said there has been no evidence so far of human-to-human transmission but warned that H7N9 was "one of the most lethal" influenza viruses ever seen. Chinese researchers, reporting in The Lancet recently, said they had confirmed poultry as a source of the virus among humans. Chinese health officials have acknowledged so-called "family clusters," where members of a single family have become infected, but have not established any confirmed instances of human-to-human transmission.
The National Center for Emerging and Zoonotic Infectious Diseases aims to prevent disease, disability, and death caused by a wide range of infectious diseases. We focus on diseases that have been around for many years, emerging diseases (those that are new or just recently identified), and zoonotic diseases (those spread from animals to people). Our work is guided in part by a holistic "One Health" strategy, which recognizes the vital interconnectedness of microbes and the environment. Through a comprehensive approach involving many scientific disciplines, we can attain better health for humans and animals and improve our environment.
(a) In general
(1) Emergency uses Notwithstanding any provision of this chapter and section 351 of the Public Health Service Act [42 U.S.C. 262], and subject to the provisions of this section, the Secretary may authorize the introduction into interstate commerce, during the effective period of a declaration under subsection (b) of this section, of a drug, device, or biological product intended for use in an actual or potential emergency (referred to in this section as an “emergency use”).
(2) Approval status of product An authorization under paragraph (1) may authorize an emergency use of a product that—
(A) is not approved, licensed, or cleared for commercial distribution under section 355, 360 (k), or 360e of this title or section 351 of the Public Health Service Act [42 U.S.C. 262] (referred to in this section as an “unapproved product”); or
(B) is approved, licensed, or cleared under such a provision, but which use is not under such provision an approved, licensed, or cleared use of the product (referred to in this section as an “unapproved use of an approved product”).
(3) Relation to other uses An emergency use authorized under paragraph (1) for a product is in addition to any other use that is authorized for the product under a section of this chapter or the Public Health Service Act referred to in paragraph (2)(A).