Direct Final Rule and Notice of Proposed Rulemaking for Establishment of a User Fee for Filovirus Testing of Nonhuman Primates

Since 1975, CDC has prohibited the importation of nonhuman primates (NHPs) except for science, education, or exhibition purposes. These restrictions were created because NHPs can carry infectious diseases that are harmful and sometimes fatal to humans. Examples of these diseases include tuberculosis, yellow fever, monkeypox, and hemorrhagic fever caused by filoviruses such as Ebola and Marburg.

A Direct Final Rule (DFR) and Notice of Proposed Rulemaking (NPRM) were developed to amend the Foreign Quarantine Regulations for the Importation of Nonhuman Primates (42 CFR Part 71.53), in order to establish a user fee for filovirus testing of NHPs. Filovirus testing has been required since 1990 for African green, cynomolgus, and rhesus monkeys that die for any reason other than trauma during the mandatory 31-day quarantine period. CDC has one of the few laboratories in the United States that can safely handle NHP samples and that has the reagents required for the testing.

On February 10, 2012, the Department of Health and Human Services (HHS) and the Centers for Disease Control and Prevention (CDC) posted a DFR and an NPRM amending 42 CFR § 71.53 to establish a user fee for filovirus testing of nonhuman primates. Please see the docket details for the NPRM and DFR on FederalRegister.gov. HHS/CDC will accept comments from the public for 60 days following publication. To make a comment on the proposed regulation, visit the Regulations.gov website. Comments about this NPRM and DFR must be received by April 10, 2012.