07-5884. Amendment to January 26, 2007 Declaration Under the Public Readiness and Emergency Preparedness Act

AGENCY:

Office of the Assistant Secretary for Preparedness and Response (ASPR), HHS.

ACTION:

Amendment (to the January 26, 2007 Declaration under the Public Readiness and Emergency Preparedness Act).

SUMMARY:

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 a credible risk that avian influenza viruses spread and evolve into strains capable of causing a pandemic of human influenza.

Amendment: Whereas, the H7 and H9 subtypes of avian influenza viruses are viewed as likely candidates to evolve into an influenza virus strain capable of causing a pandemic of human influenza; and

Whereas, in accordance with section 319F-3(b)(6) of the Public Health Service Act (42 U.S.C. 247d-6d(b)) (“the Act”), I have considered the desirability of encouraging the design, development, clinical testing or investigation, manufacturing and product formulation, labeling, distribution, packaging, marketing, promotion, sale, purchase, donation, dispensing, prescribing, administration, licensing, and use of these additional medical countermeasures with respect to the category of diseases and population described in sections II and IV of the declaration published in Federal Register on February 1, 2007 (72 FR 4710) (“the Original Declaration”);

Therefore, pursuant to section 319F-3(b) of the Act, I have determined there is a credible risk that the spread of the H7 and H9 subtypes of avian influenza viruses and resulting disease could in the future constitute a public health emergency. In order to reflect the addition of medical countermeasures specific to the H7 and H9 subtypes of influenza viruses, the Original Declaration is hereby amended as follows:

First “whereas” clause, first sentence, insert “H7 and H9 vaccines” following “(H5N1).”

Second “whereas” clause, first sentence, insert “H7 and H9” following “H5N1” to read “Whereas an H5N1, [H7 and H9] avian influenza viruse[s] may evolve into strain[s] * * *.”

In Section I, paragraph 2, first sentence insert “H7 and H9” following “(H5N1)” to read “* * * pandemic countermeasure influenza A (H5N1, [H7 and H9]) vaccine[s].”

In Section I, paragraph 2, third sentence insert “H7 and H9” following “(H5N1)” to read “* * * pandemic countermeasure influenza A (H5N1, [H7 and H9]) vaccine[s] * * *.”

In Section II, paragraph 1, insert “or an H7 or H9” following “(H5N1).”

In Section VIII, strike the sentence “This Declaration has not previously been amended.” and replace it with: “This is the first amendment to this Declaration. The Original Declaration was published in the Federal Register at 72 FR 4710.”

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.

DATES:

This notice and the attached declaration are effective November 30, 2007.

FOR FURTHER INFORMATION CONTACT:

RADM W. Craig Vanderwage, MD, 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).

Dated: November 21, 2007.

Michael O. Leavitt,

Secretary.