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# Info Collection Revision on NDA Form
- URL: https://www.fdaweb.com/info-collection-revision-on-nda-form/
- Published: 2024-03-06T12:00:00.000Z
- Updated: 2026-09-14T14:24:38.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5156500

*Federal Register* notice: FDA has submitted to OMB an information collection revision entitled “Applications for FDA Approval To Market a New Drug — 21 CFR Part 314.” The collection supports statutory and regulatory authorities that govern new drugs. The agency is revising Form FDA 3898 (Drug Master File) and the accompanying instructions to allow for multiple selections of submission types and to clarify the number of digits to be entered for the holder and establishment registration numbers. It is also revising the collection to include the submission of information pursuant to the CREATES Act, which enables developers of potential drug and biological products to use the CREATES pathway to obtain samples of brand products that are needed to support their applications. Relevant products include those submitted in generic drug applications under section 505(j) of the FD&C Act and NDAs submitted under section 505(b)(2) of the FD&C Act, and biosimilar products submitted under section 351(k) of the Public Health Service Act. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2024-03-06/pdf/2024-04715.pdf?ref=fdaweb.com).