[1] A rare disease or disorder is defined in the U.S. as one affecting fewer than 200,000 Americans.

S. 1379 (Rare Diseases Act of 2001) was introduced in 2001 by Sen. Edward Kennedy (D-MA) but died in committee.

[6] The NIH established the Rare Diseases Clinical Research Network in 2003 with a $51 million grant over five years in response to the law.

"[7] The RDCRC's will be able to utilize the resources available at the 82 General Clinical Research Centers distributed across the United States.

As of October 2014, the network is composed of around 2,600 researchers which includes NIH staff, academic investigators and members of 98 patient advocacy groups.