2010-7529. Determination and Declarations Regarding Emergency Use of Certain In vitro Diagnostic, Antiviral, and Personal Respiratory Products Accompanied by Emergency Use Information

AGENCY:

Office of the Secretary (OS), HHS.

ACTION:

Notice.

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 Act (FFDCA), 21 U.S.C. 360bbb-3(b)(4). On April 26, 2009, the then Acting Secretary of HHS determined that a public health emergency exists nationwide involving Swine Influenza A (now known as 2009 H1N1 Influenza A, or 2009 H1N1 Influenza) that affects or has significant potential to affect national security. On the basis of this determination, on April 26 and April 27, 2009, the then Acting Secretary declared emergencies justifying the authorization of emergency use of certain in vitro diagnostic, antiviral, and personal respiratory protection products accompanied by emergency use information subject to the terms of any authorization issued by the Commissioner of Food and Drugs (Commissioner) under 21 U.S.C. 360bbb-3(a). The then Acting Secretary also specified that these declarations are declarations of emergency as defined by former Secretary Michael O. Leavitt in the October 10, 2008 Declaration under the Public Readiness and Emergency Preparedness (PREP) Act for Influenza Antivirals Oseltamivir Phosphate and Zanamavir, as amended, and the December 17, 2008 Declaration under the PREP Act for Pandemic Influenza Diagnostics, Personal Respiratory Protection Devices, and Respiratory Support Devices. The Secretary renewed the then Acting Secretary's determination that a public health emergency exists nationwide involving Swine Influenza A (now known as 2009 H1N1 Influenza) on July 24, October 1, and December 28, 2009, and March 26, 2010. Also on March 26, 2010, the Secretary renewed the then Acting Secretary's declarations of emergency justifying the authorization of emergency use of certain in vitro diagnostic, antiviral, and personal respiratory protection products accompanied by emergency use information subject to the terms of any authorization issued by the Commissioner of Food and Drugs (Commissioner) under 21 U.S.C. 360bbb-3(a).

DATES:

The declaration of an emergency justifying the authorization of emergency use of certain in vitro diagnostic products is renewed effective March 26, 2010. The declaration of an emergency justifying the authorization of certain antiviral products is renewed effective March 26, 2010. The declaration of an emergency justifying the authorization of emergency use of certain respiratory protection products is renewed effective March 26, 2010.

FOR FURTHER INFORMATION CONTACT:

Nicole Lurie, M.D., MSPH, Assistant Secretary for Preparedness and Response, Office of the Secretary, Department of Health and Human Services, 200 Independence Avenue, SW., Washington, DC 20201, Telephone [phone] (this is not a toll free number).

SUPPLEMENTARY INFORMATION:

I. Background

Under Section 564 of the FFDCA, the Commissioner, acting under delegated authority from the Secretary of HHS, may issue an Emergency Use Authorization (EUA) authorizing the emergency use of an unapproved drug, an unapproved or uncleared device, or an unlicensed biological product, or an unapproved use of an approved drug, approved or cleared device, or licensed biological product. Before an EUA may be issued, the Secretary of HHS must declare an emergency justifying the authorization based on one of three determinations: A determination of a domestic emergency, or a significant potential for a domestic emergency, by the Secretary of Homeland Security; a determination of a military emergency, or a significant potential for a military emergency, by the Secretary of Defense; or a determination of a public health emergency by the Secretary of HHS. See 21 U.S.C. 360bbb-3(b)(1). In the case of a determination by the Secretary of HHS (as was made here), the Secretary must determine that a public health emergency exists under section 319 of the Public Health Service (PHS) Act that affects, or has a significant potential to affect, national security, and that involves a specified biological, chemical, radiological, or nuclear agent or agents, or a specified disease or condition that may be attributable to such agent or agents. Based on such a determination, the Secretary of HHS may then declare an emergency that justifies the EUA, at which point the Commissioner may issue an EUA if the criteria for issuance of an authorization under section 564 of the FFDCA are met.

The Centers for Disease Control and Prevention (CDC), HHS, requested that the Food and Drug Administration (FDA) issue EUAs for certain in vitro diagnostic, antiviral, and personal respiratory protection products accompanied by emergency use information. The determination of a public health emergency by the then Acting Secretary and declarations of an emergency by the then Acting Secretary based on that determination, published at 74 FR 38628 (August 4, 2009), enabled the then Acting Commissioner to issue EUAs for certain in vitro diagnostic, antiviral, and personal respiratory protection products, published at 74 FR 38636 (August 4, 2009), 71 FR 38641 (August 4, 2009) and 71 FR 38645 (August 4, 2009). The CDC has requested that the FDA continue these EUAs to support continued surveillance of 2009 H1N1 influenza through use of certain in vitro diagnostic products. Continuation of the EUAs is also important to support continued availability and disposition of certain antiviral products to treat individuals who are ill following exposure to 2009 H1N1 influenza and to support continued availability and disposition of certain personal respiratory products to help reduce wearer exposure to airborne viruses during the 2009 H1N1 influenza emergency. The renewed determination of a public health emergency by the Secretary of HHS and the renewed declarations of an emergency by the Secretary of HHS based on that determination justify the authorization of the emergency use of the above products.

In this public health emergency involving 2009 H1N1 influenza, time continues to be of the essence in detecting, preventing, and treating illness and death by getting in vitro diagnostic, antiviral, and personal respiratory protection products, accompanied by emergency use information, to the general public, laboratories, and public health and health care professionals. By continuing to distribute certain in vitro diagnostic products accompanied by emergency use information, public health and health care professionals can ensure that any continued spread of the 2009 H1N1 influenza is quickly and accurately detected. By dispensing certain personal respiratory products accompanied by emergency use information, the appropriate State and/or public health authority(ies) can ensure that the products are provided quickly, as appropriate, to help reduce wearer exposure to airborne germs. By dispensing certain antiviral products accompanied by emergency use information, public health and medical professionals and the authorities having jurisdiction to respond to the emergency in each locality can ensure that the products are provided quickly, as appropriate, to treat those who may have been exposed or are ill.

This is one part of the Federal Government's strategy to encourage continued preparedness at all levels of government to enable the nation to respond effectively in response to this public health emergency.

II. Determination of the Secretary of Health and Human Services

On March 26, 2010, the Secretary renewed the April 26, 2009 determination by then Acting Secretary Charles E. Johnson that a public health emergency exists nationwide involving Swine Influenza A (now called 2009 H1N1 Influenza) that affects or has significant potential to affect national security. The Secretary renewed the Acting Secretary's determination, after consultation with public health officials as necessary and pursuant to authority under section 319 of the Public Health Service Act 42 U.S.C. 247d, because the 2009 H1N1 Influenza outbreak remains a worldwide public health threat. The Secretary previously renewed the Acting Secretary's determination on July 24, 2009, October 1, 2009, and December 28, 2009.

III. Declarations of the Secretary of Health and Human Services

On March 26, 2010, the Secretary renewed the April 26, 2009 declaration by then Acting Secretary Charles E. Johnson of an emergency justifying the authorization of the emergency use of certain in vitro diagnostics for detection of Swine Influenza A (now called 2009 H1N1 Influenza) accompanied by emergency use information subject to the terms of any authorization issued under 21 U.S.C. 360bbb-3(a). This renewal was made on the basis of the April 26, 2009 determination by then Acting Secretary Charles E. Johnson, pursuant to section 319 of the Public Health Service Act, 42 U.S.C. 247d, that a public health emergency exists nationwide involving Swine Influenza A (now called 2009 H1N1 Influenza) that affects or has significant potential to affect national security, a determination which was renewed on July 24, 2009, October 1, 2009, December 28, 2009 and March 26, 2010 because 2009 H1N1 flu outbreak remains a public health threat and the Department should use all available tools to ensure that the nation is prepared. The renewal of this April 26, 2009 declaration was made pursuant to section 564(b) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. 360bbb-3(b). In renewing the declaration, the Secretary further specified that the declaration is a declaration of emergency, as defined in the December 17, 2008 Declaration under the Public Readiness and Emergency Preparedness Act for Influenza Diagnostics, Personal Respiratory Protection Devices, and Respiratory Support Devices, 73 FR 78362 (December 22, 2008).

Also on March 26, 2010, the Secretary renewed the April 26, 2010 declaration by then Acting Secretary Charles E. Johnson of an emergency justifying the authorization of the emergency use of certain products from the neuraminidase class of Antivirals Oseltamivir Phosphate and Zanamivir accompanied by emergency use information subject to the terms of any authorization issued under 21 U.S.C. 360bbb-3(a). This renewal was made on the basis of the April 26, 2009 determination by then Acting Secretary Charles E. Johnson, pursuant to section 319 of the Public Health Service Act, 42 U.S.C. 247d, that a public health emergency exists nationwide involving Swine Influenza A (now called 2009 H1N1 Influenza) that affects or has significant potential to affect national security, a determination which was renewed on July 24, 2009, October 1, 2009, December 28, 2009, and March 26, 2010 because 2009 H1N1 flu outbreak remains a public health threat and the Department should use all available tools to ensure the nation is prepared. The renewal of this April 26, 2009 declaration was made pursuant to section 564(b) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. 360bbb-3(b). In renewing the declaration, the Secretary further specified that the declaration is a declaration of emergency, as defined in the October 10, 2008 Declaration under the Public Readiness and Emergency Preparedness Act for Influenza Antivirals Oseltamivir Phosphate and Zanamivir, 73 FR 61861 (October 17, 2008), as amended at 74 FR 2913 (April 26, 2009).

Also on March 26, 2010, the Secretary renewed the April 27, 2009 declaration by then Acting Secretary Charles E. Johnson of an emergency justifying the authorization of the emergency use of certain personal respiratory protection devices, accompanied by emergency use information subject to the terms of any authorization issued under 21 U.S.C 360bbb-3(a). This renewal was made on the basis of the April 26, 2009 determination by then Acting Secretary Charles E. Johnson, pursuant to section 319 of the Public Health Service Act, 42 U.S.C. 247d, that a public health emergency exists nationwide involving Swine Influenza A (now called 2009 H1N1 Influenza) that affects or has significant potential to affect national security, a determination which was renewed on July 24, 2009, October 1, 2009, December 28, 2009 and March 26, 2010 because 2009 H1N1 flu outbreak remains a public health threat and the Department should use all available tools to ensure that the nation is prepared. The renewal of this April 27, 2009 declaration was made pursuant to section 564(b) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. 360bbb-3(b). In renewing this declaration, the Secretary further specified that the declaration is a declaration of emergency, as defined in the December 17, 2008 Declaration under the Public Readiness and Emergency Preparedness Act for Influenza Diagnostics, Personal Respiratory Protection Devices, and Respiratory Support Devices, 73 FR 78362 (December 22, 2008).

Dated: March 26, 2010.

Kathleen Sebelius,

Secretary.