---
kind: "section"
citation: "21 C.F.R. § 314.99"
title: "21"
number: "314.99"
heading: "Other responsibilities of an applicant of an ANDA."
url: "https://uscodex.org/cfr/21/314.99"
---

# §314.99. Other responsibilities of an applicant of an ANDA.

- (a) An applicant must comply with the requirements of [§ 314.65](/cfr/21/314.65.md) regarding withdrawal by the applicant of an unapproved ANDA and [§ 314.72](/cfr/21/314.72.md) regarding a change in ownership of an ANDA.
- (b) An applicant may ask FDA to waive under this section any requirement that applies to the applicant under [§§ 314.92 through 314.99](/cfr/21/314.92..314.99.md). The applicant must comply with the requirements for a waiver under [§ 314.90](/cfr/21/314.90.md). If FDA grants the applicant's waiver request with respect to a requirement under [§§ 314.92 through 314.99](/cfr/21/314.92..314.99.md), the waived requirement will not constitute a basis for refusal to approve an ANDA under [§ 314.127](/cfr/21/314.127.md).

## Notes

### Amendments

81 FR 69653, Oct. 6, 2016]

### Source

Source: 57 FR 17983, Apr. 28, 1992, unless otherwise noted.

### Authority

Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 355a, 355f, 356, 356a, 356b, 356c, 356e, 360cc, 360ddd, 360ddd-1, 371, 374, 379e, 379k-1.

### Source

Source: 50 FR 7493, Feb. 22, 1985, unless otherwise noted.

### Amendments

81 FR 69653, Oct. 6, 2016]