Department of Health and Human Services September 18, 2012 – Federal Register Recent Federal Regulation Documents

A natural re-emergence of smallpox is not deemed possible, but if it were to occur as a result of a terrorist or deliberate event, it would be a potentially devastating threat to public health worldwide and would constitute a public health emergency of international concern (PHEIC) under the International Health Regulations (IHR) (2005). A case of smallpox detected by a member state requires notification to World Health Organization (WHO) as soon as possible, and any confirmed smallpox case would generate an immediate global public health response. WHO must rely on fast and reliable laboratory diagnostic capacity worldwide to be able to identify a re-emergence of smallpox, particularly in countries where systemic orthopoxvirus infections such as monkeypox, vaccinia virus infection or cowpox, and other non-pox viral rash illnesses, such as chicken pox, may cause clinical diagnostic confusion. Over the past 10 years, clinical virology laboratory diagnostics has been evolving and increasingly rely on molecular techniques. This is also true with laboratory diagnoses of poxvirus infections. Precise and consistent identification of orthopoxviruses, in particular variola viruses, is now achievable using such molecular techniques as real-time Polymerase Chain Reaction (unlike earlier techniques that may have relied on direct virus isolation and identification). WHO must be alerted when there is a potential or actual smallpox infection. Early detection and confirmation of smallpox cannot rely solely on the two WHO Collaborating Centres for smallpox and other poxvirus infections. In order to facilitate and support a prompt and effective response to mitigate the spread of the disease, these two Centres should be supported by a worldwide network of reliable laboratories able to perform PCR and real-time PCR diagnostics enabling initial detection and identification of smallpox events. Additionally, the U.S. Government supports the development of other medical products, including vaccines and drugs, for use within the U.S. upon verification of a smallpox case. The U.S. government, through the Office of the Assistant Secretary for Preparedness and Response (ASPR), has successfully developed vaccine products, and is actively engaged in the development of several drug candidates for smallpox therapies, which require access to the Variola virus to satisfy regulatory requirements for product approvals.

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of August 3, 2012 (77 FR 46441). The document announced that a proposed collection of information had been submitted to the Office of Management and Budget for review and clearance under the Paperwork Reduction Act of 1995. The document published with incorrect FDA form numbers. This document corrects those errors.