SEC. 525. [21 USC §360aa] Recommendations for Investigations of Drugs for Rare Diseases or Conditions

 1 (a) The sponsor of a drug for a disease or condition which is rare in the States may request the Secretary to provide written recommendations for the nonclinical and clinical investigations which must be conducted with the drug before—

(1) it may be approved for such disease or condition under section 505, or

(2) if the drug is a biological product, it may be licensed for such disease or condition under section 351 of the Public Health Service Act.

If the Secretary has reason to believe that a drug for which a request is made under this section is a drug for a disease or condition which is rare in the States, the Secretary shall provide the person making the request written recommendations for the nonclinical and clinical investigations which the Secretary believes, on the basis of information available to the Secretary at the time of the request under this section, would be necessary for approval of such drug for such disease or condition under section 505 or licensing of such drug for such disease or condition under section 351 of the Public Health Service Act.

(b) The Secretary shall by regulation promulgate procedures for the implementation of subsection (a).

 

Footnote

 

 1. Section 5 of the Orphan Drug Act (21 U.S.C. 360ee) (Public Law 97–414), which is included in the appendix, establishes a program to make grants and enter into contracts regarding the development of drugs for rare diseases and conditions. Authorizations of appropriations for that program are currently provided through fiscal year 2006. See section 3 of Public Law 107–281 (116 Stat. 1993).