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Co-Authored-By: Claude Opus 4.8 <noreply@anthropic.com>
2026-07-06 10:51:44 -04:00

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LegalText 21 U.S.C. § 379k Information system us united_states_code code_section 21 FOOD AND DRUGS 9 FEDERAL FOOD, DRUG, AND COSMETIC ACT 379k 21 U.S.C. § 379k current 119-100 2026-06-26 official https://uscode.house.gov/download/releasepoints/us/pl/119/100/xml_usc21@119-100.zip /us/usc/t21/s379k data/legal/raw/us/code/title-21/usc21.xml 71a79738aea554e738ba14244ec99125c10525a2043a19ce95a0c7d082acdc70 3dbd7a61c8616baefb8459bd8dac3b93242106deb416308c8d4dd5a9143176d1 2a70e535cfd1e35554d8d187c704c9501853919a929f844712e9848830422ba0 2026-07-04 official
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21 U.S.C. § 379k - Information system

Text

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. 105115, title IV, § 407(a), Nov. 21, 1997, 111 Stat. 2370; renumbered § 745, Pub. L. 110316, title II, § 202(a), Aug. 14, 2008, 122 Stat. 3515.)

Notes

Statutory Notes and Related Subsidiaries

Effective DateSection effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of Pub. L. 105115, set out as an Effective Date of 1997 Amendment note under section 321 of this title.

Report on Status of SystemPub. L. 105115, 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.