E9-14412. Pandemic Influenza Antivirals-Amendment

AGENCY:

Department of Health and Human Services, Office of the Secretary.

Subject: Pandemic Influenza Antivirals—Amendment.

Authority: 42 U.S.C. 247d-6d.

ACTION:

Notice of amendment (to the October 10, 2008 Declaration under the Public Readiness and Emergency Preparedness Act).

SUMMARY:

Amendment to declaration pursuant to section 319F-3 of the Public Health Service Act (42 U.S.C. 247d-6d) to provide targeted liability protections for pandemic countermeasures based on the Acting Secretary's April 26 determination, under section 319F-3(b) of the Act, that the risk that the spread of H1N1 swine influenza viruses (now known as 2009 H1N1 Influenza A, or 2009 H1N1 influenza) and resulting disease constitutes a public health emergency.

DATES:

This notice and the attached amendment are effective as of April 26, 2009.

FOR FURTHER INFORMATION CONTACT:

RADM W.C. Vanderwagen, 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).

HHS Secretary's Amendment to the Declaration for the Use of the Public Readiness and Emergency Preparedness Act for the Influenza Antivirals Oseltamivir Phosphate (Tamiflu®) and Zanamivir (Relenza®) Dated October 10, 2008

Whereas the October 10, 2008 declaration for Oseltamivir Phosphate (Tamiflu(®)) and Zanamivir (Relenza®) (“Original Declaration”) applies to administration of the aforementioned covered countermeasures to address the threat of or actual human influenza that results from the infection of humans with highly pathogenic avian influenza A viruses or other highly pathogenic influenza viruses causing a pandemic following exposure to the viruses;

Whereas the current detection of H1N1 swine flu in Mexico and the United States may have the potential to evolve into an influenza strain capable of causing a pandemic of human influenza;

Whereas the aforementioned covered countermeasures may be effective to protect persons from either the threat of H1N1 swine influenza, or to treat persons with H1N1 swine influenza;

Whereas the findings made by the Secretary in the Original Declaration continue to apply generally, and apply with equal force as to swine influenza;

Whereas in accordance with section 319F-3(b)(6) of the Act (42 U.S.C. 247d-6d(b), I have considered the desirability of encouraging the design, development, clinical testing or investigation, manufacturing, labeling, distribution, formulation, packaging, marketing, promotion, sale, purchase, donation, dispensing, prescribing, administration, licensing or approval, and use of additional covered countermeasures with respect to the category of disease in section II of the Original Declaration, as amended, and have found it desirable to encourage such activities for these additional covered countermeasures, and;

Whereas to encourage the design, development, clinical testing or investigation, manufacturing and product formulation, labeling, distribution, packaging, marketing, promotion, sale, purchase, donation, dispensing, prescribing, administration, licensing or approval, and use of medical countermeasures with respect to the category of disease described in section II of the Original Declaration, as amended, it is advisable, in accordance with section 319F-3(a) and (b) of the Act, to provide immunity from liability for covered persons, as that term is defined at section 319F-3(i)(2) of the Act, and to include as such covered persons such other qualified persons as I have identified in section VI of the Original Declaration, as amended;

Therefore pursuant to section 319F-3(b) of the Act, I have determined that the risk that the spread of H1N1 swine influenza viruses and resulting disease constitutes a public health emergency. In order to clarify that the Original Declaration applies to H1N1 swine flu influenza, as well as other influenza strains which originate from animals and which have pandemic potential, the Original Declaration, is hereby amended as follows:

Strike the current section II, “Category of Disease,” in its entirety and replace as follows:

II. Category of Disease (As Required by Section 319F-3(b)(2)(A) of the Act)

The category of disease, health condition, or threat to health for which I am recommending the administration or use of the Covered Countermeasures is the threat of or actual human influenza that results from the infection of humans with highly pathogenic avian H5N1 influenza A viruses or other animal influenza A viruses (including, but not limited to, H1N1 swine influenza) that are, or may be capable of developing into, a pandemic strain.

In section VIII, strike the section in its entirety and replace it with the following: “This Declaration has been amended. The Original Declaration was published in the Federal Register at 73 FR 61861. This is the first amendment to the Original Declaration. Any future amendment to this Declaration will be published in the Federal Register, pursuant to section 319F-3(b)(4) of the Act.”

All other provisions of the Original Declaration remain in full force.

This amendment to the Declaration will be published in the Federal Register, pursuant to section 319F-3(b)(4) of the Act.

Dated: June 11, 2009.

Kathleen Sebelius,

Secretary.