118 STAT. 894 PUBLIC LAW 108–282—AUG. 2, 2004 intended use, and that person is able to assure the availability of sufficient quantities of the drug to meet the needs for which the drug is intended; the Secretary shall issue an order refusing to conditionally approve the application. If, after such notice and opportunity for an informal hearing, the Secretary finds that paragraphs (1) through (3) do not apply, the Secretary shall issue an order conditionally approving the application effective for one year and publish a Federal Register notice of the conditional approval. Any order issued under this subsection refusing to conditionally approve an application shall state the findings upon which it is based. ‘‘(d) A conditional approval under this section is effective for a 1 year period and is thereafter renewable by the Secretary annually for up to 4 additional 1 year terms. A conditional approval shall be in effect for no more than 5 years from the date of approval under subsection (b)(1) or (c) of this section unless extended as provided for in subsection (h) of this section. The following shall also apply: ‘‘(1) No later than 90 days from the end of the 1 year period for which the original or renewed conditional approval is effective, the applicant may submit a request to renew a conditional approval for an additional 1 year term. ‘‘(2) A conditional approval shall be deemed renewed at the end of the 1 year period, or at the end of a 90 day extension that the Secretary may, at the Secretary’s discretion, grant by letter in order to complete review of the renewal request, unless the Secretary determines before the expiration of the 1 year period or the 90 day extension that— ‘‘(A) the applicant failed to submit a timely renewal request; ‘‘(B) the request fails to contain sufficient information to show that— ‘‘(i) the applicant is making sufficient progress toward meeting approval requirements under section 512(d)(1)(E), and is likely to be able to fulfill those requirements and obtain an approval under section 512 before the expiration of the 5 year maximum term of the conditional approval; ‘‘(ii) the quantity of the drug that has been distrib uted is consistent with the conditionally approved intended use and conditions of use, unless there is adequate explanation that ensures that the drug is only used for its intended purpose; or ‘‘(iii) the same drug in the same dosage form for the same intended use has not received approval under section 512, or if such a drug has been approved, that the holder of the approved application is unable to assure the availability of sufficient quantities of the drug to meet the needs for which the drug is intended; or ‘‘(C) any of the provisions of section 512(e)(1) (A) through (B) or (D) through (F) are applicable. ‘‘(3) If the Secretary determines before the end of the 1 year period or the 90 day extension, if granted, that a condi tional approval should not be renewed, the Secretary shall issue an order refusing to renew the conditional approval, and such conditional approval shall be deemed withdrawn and no Deadline. Applicability. Federal Register, publication.
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