21 U.S.C. § 379k — Information system

The Secretary shall establish and maintain an information system to track the status and progress of each application or submission (including a petition, notification, or other similar form of request) submitted to the Food and Drug Administration requesting agency action. (June 25, 1938, ch. 675, § 745, formerly § 741, as added Pub. L. 105–115, title IV, § 407(a) , Nov. 21, 1997 , 111 Stat. 2370 ; renumbered § 745, Pub. L. 110–316, title II, § 202(a) , Aug. 14, 2008 , 122 Stat. 3515 .) Statutory Notes and Related Subsidiaries Effective Date Section effective 90 days after Nov. 21, 1997 , except as otherwise provided, see section 501 of Pub. L. 105–115 , set out as an Effective Date of 1997 Amendment note under section 321 of this title . Report on Status of System Pub. L. 105–115, title IV, § 407(b) , Nov. 21, 1997 , 111 Stat. 2370 , provided that not later than 1 year after Nov. 21, 1997 , Secretary of Health and Human Services was to submit report to Congress on status of system to be established under this section, including projected costs of system and concerns about confidentiality. CFR Title Parts 21 5 , 7 , 10 , 11 , 12 , 13 , 14 , 15 , 16 , 20 , 25

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