Sec. 3. ENHANCING NEW DRUG DEVELOPMENT
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/statute-compilations/comps-11760/sec-3A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
## SEC. 3 ENHANCING NEW DRUG DEVELOPMENT Section 303 of the Controlled Substances Act (21 U.S.C. 823) is amended by adding at the end the following: > > ### “(i) > > > ####
(1)> > For purposes of registration to manufacture a controlled substance under subsection
(d)for use only in a clinical trial, the Attorney General shall register the applicant, or serve an order to show cause upon the applicant in accordance with section 304(c), not later than 180 days after the date on which the application is accepted for filing. > > > #### “(2) > > For purposes of registration to manufacture a controlled substance under subsection
(a)for use only in a clinical trial, the Attorney General shall, in accordance with the regulations issued by the Attorney General, issue a notice of application not later than 90 days after the application is accepted for filing. Not later than 90 days after the date on which the period for comment pursuant to such notice ends, the Attorney General shall register the applicant, or serve an order to show cause upon the applicant in accordance with section 304(c), unless the Attorney General has granted a hearing on the application under section 1008(i) of the Controlled Substances Import and Export Act.” > .
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Sec. 3
ENHANCING NEW DRUG DEVELOPMENT
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