United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2003_register executive 2010-09-23 article Notices D09002ee1c81740fb D09002ee1c81741bc United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Food and Drug Administration originator org United States Government Agency or Subagency The Food and Drug Administration (FDA) is announcing that we (FDA) have concluded that pentetate calcium trisodium (Ca-DTPA) and pentetate zinc trisodium (Zn-DTPA), when produced under conditions specified in approved new drug applications (NDAs), can be found to be safe and effective for the treatment of internal contamination with plutonium, americium, or curium to increase the rates of elimination. We encourage the submission of NDAs for Ca-DTPA and Zn- DTPA drug products. We are also announcing the availability of a guidance for industry entitled "Calcium-DTPA and Zinc-DTPA Drug Products--Submitting a New Drug Application." This guidance is intended to assist manufacturers who plan to submit NDAs for Ca-DTPA and Zn-DTPA. 68 FR 53984 https://www.govinfo.gov/app/details/FR-2003-09-15/03-23489 03-23489 fr15se03-87 4160-01-S Docket No. 2003D-0399 https://www.govinfo.gov/app/details/FR-2003-09-15/03-23489 https://www.govinfo.gov/content/pkg/FR-2003-09-15/html/03-23489.htm https://www.govinfo.gov/content/pkg/FR-2003-09-15/pdf/03-23489.pdf 6 p. 53984 53989 68 FR 53984 Guidance for Industry on Pentetate Calcium Trisodium and Pentetate Zinc Trisodium for Treatment of Internal Contamination with Plutonium, Americium, or Curium; Availability; Federal Register Vol. 68, Issue NOTICE 03-23489 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Docket No. 2003D-0399 4160-01-S 03-23489 Notice.

The Food and Drug Administration (FDA) is announcing that we (FDA) have concluded that pentetate calcium trisodium (Ca-DTPA) and pentetate zinc trisodium (Zn-DTPA), when produced under conditions specified in approved new drug applications (NDAs), can be found to be safe and effective for the treatment of internal contamination with plutonium, americium, or curium to increase the rates of elimination. We encourage the submission of NDAs for Ca-DTPA and Zn- DTPA drug products. We are also announcing the availability of a guidance for industry entitled "Calcium-DTPA and Zinc-DTPA Drug Products--Submitting a New Drug Application." This guidance is intended to assist manufacturers who plan to submit NDAs for Ca-DTPA and Zn-DTPA.

Kyong Kang, Center for Drug Evaluation and Research (HFD-160), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-7510. Reports and guidance documents; availability, etc.: Pentetate calcium trisodium (Ca-DTPA) and pentetate zinc trisodium (Zn-DTPA); safe and effective for internal contamination with plutonium, americum, or cur, http://www.doh.wa.gov/ehp/rp/rp-prf.htm http://www.fda.gov/cder/drug/infopage/dtpa/default.htm http://www.fda.gov/cder/guidance/index.htm http://www.fda.gov/dockets/ecomments http://www.fda.gov/ohrms/dockets/default.htm Vol. 68, no. 178 Office of the Federal Register, National Archives and Records Administration 2003-09-15 continuing daily deposited born digital 267 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2003-09-15 P0b002ee1809c8e9d 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr15se03 https://www.govinfo.gov/app/details/FR-2003-09-15 https://www.govinfo.gov/content/pkg/FR-2003-09-15/pdf/FR-2003-09-15.pdf https://www.govinfo.gov/content/pkg/FR-2003-09-15/xml/FR-2003-09-15.xml fdlp 53871 54122 DGPO 2010-09-23 2024-06-07 FR-2003-09-15 machine generated eng FR FR-2003-09-15 68 178