
From the U.S. Code Online via GPO Access
[wais.access.gpo.gov]
[Laws in effect as of January 2, 2001]
[Document not affected by Public Laws enacted between
  January 2, 2001 and January 28, 2002]
[CITE: 21USC360dd]

 
                        TITLE 21--FOOD AND DRUGS
 
             CHAPTER 9--FEDERAL FOOD, DRUG, AND COSMETIC ACT
 
                     SUBCHAPTER V--DRUGS AND DEVICES
 
              Part B--Drugs for Rare Diseases or Conditions
 
Sec. 360dd. Open protocols for investigations of drugs for rare 
        diseases or conditions
        
    If a drug is designated under section 360bb of this title as a drug 
for a rare disease or condition and if notice of a claimed exemption 
under section 355(i) of this title or regulations issued thereunder is 
filed for such drug, the Secretary shall encourage the sponsor of such 
drug to design protocols for clinical investigations of the drug which 
may be conducted under the exemption to permit the addition to the 
investigations of persons with the disease or condition who need the 
drug to treat the disease or condition and who cannot be satisfactorily 
treated by available alternative drugs.

(June 25, 1938, ch. 675, Sec. 528, as added Pub. L. 97-414, Sec. 2(a), 
Jan. 4, 1983, 96 Stat. 2051.)
