Rules and Regulations. Notice
/register/2020/07/14/2020-15095·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
Agency: Food and Drug Administration, HHS
Action: Notice
Citation: FR Doc. 2020-15095 · Docket No. FDA-2020-N-1313
Summary
The Food and Drug Administration (FDA or Agency) Center for Biologics Evaluation and Research (CBER) is announcing support for the current version of Clinical Data Interchange Standards Consortium (CDISC) Standard for the Exchange of Nonclinical Data (SEND) and an update to the FDA Data Standards Catalog for the submission of nonclinical data in new drug applications (NDAs), abbreviated new drug applications (ANDAs), certain biologics license applications (BLAs), and certain investigational new drug applications (INDs). This update does not apply to noncommercial INDs for a product that is not intended for commercial distribution (research and investigator-sponsored INDs); INDs and BLAs for devices that are regulated by CBER as biological products under the Public Health Services (PHS) Act; and submissions for blood and blood components, including Source Plasma.
Supplementary Information
CBER is announcing support for the current version of CDISC SEND and an update to the FDA Data Standards Catalog for the submission of nonclinical data in NDAs, ANDAs, BLAs, and certain INDs. This update does not apply to: (1) Noncommercial INDs for a product that is not intended for commercial distribution (research and investigator-sponsored INDs); (2) INDs and BLAs for devices that are regulated by CBER as biological products under section 351 of the PHS Act (42 U.S.C. 262); and (3) submissions for blood and blood components, including Source Plasma. In section 745A(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 379k-1(a)), Congress granted explicit statutory authorization to FDA to specify in guidance the format for the electronic submissions required under that section. In the Federal Register of December 18, 2014 (79 FR 75568), FDA announced a final guidance for industry entitled “Providing Regulatory Submissions in Electronic Format—Standardized Study Data.” The guidance is available on FDA's Study Data Standards Resources web page at . The guidance implemented the electronic submission requirements of section 745A(a) of the FD&C Act for study data contained in NDAs, ANDAs, BLAs, applications under subsection (a) or (k) of section 351 of the PHS Act, and certain INDs. The initial timetable for the implementation of electronic submission requirements for study data was December 17, 2016. The guidance states that a Federal Register notice will specify the transition date for all new standards (with the month and day for the transition date corresponding to March 15). The transition date for support of CDISC SEND is March 15, 2021, for CBER. Although SEND is now supported by CBER and sponsors or applicants are encouraged to begin using it, the SEND standard will only be required in studies that start 24 months after the transition date of March 15, 2021. The Catalog will list March 15, 2023, as the “date requirement begins” for CBER. When multiple versions of an FDA-supported standard are listed in the Catalog, sponsors or applicants can select a version to use. Dated: July 8, 2020. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2020-15095 Filed 7-13-20; 8:45 am]