---
kind: "section"
citation: "21 C.F.R. § 10.50"
title: "21"
number: "10.50"
heading: "Promulgation of regulations and orders after an opportunity for a formal evidentiary public hearing."
url: "https://uscodex.org/cfr/21/10.50"
---

# §10.50. Promulgation of regulations and orders after an opportunity for a formal evidentiary public hearing.

- (a) The Commissioner shall promulgate regulations and orders after an opportunity for a formal evidentiary public hearing under [part 12](/cfr/21/part12.md) whenever all of the following apply:
  - (1) The subject matter of the regulation or order is subject by statute to an opportunity for a formal evidentiary public hearing.
  - (2) The person requesting the hearing has a right to an opportunity for a hearing and submits adequate justification for the hearing as required by [§§ 12.20 through 12.22](/cfr/21/12.20..12.22.md) and other applicable provisions in this chapter, e.g., §§ [314.200](/cfr/21/314.200.md), [514.200](/cfr/21/514.200.md), and [601.7(a)](/cfr/21/601.7.md?p=a).
- (b) The Commissioner may order a formal evidentiary public hearing on any matter whenever it would be in the public interest to do so.
- (c) The provisions of the act, and other laws, that afford a person who would be adversely affected by administrative action an opportunity for a formal evidentiary public hearing as listed below. The list imparts no right to a hearing where the statutory section provides no opportunity for a hearing.
  - (1) [Section 401](/cfr/21/401.md) on any action for the amendment or repeal of any definition and standard of identity for any dairy product (including products regulated under parts [131](/cfr/21/part131.md), [133](/cfr/21/part133.md), and 135 of this chapter) or maple sirup (regulated under [§ 168.140](/cfr/21/168.140.md) of this chapter).
  - (2) **Section 403(j) on regulations for labeling of foods for special dietary uses.**
  - (3) **Section 404(a) on regulations for emergency permit control.**
  - (4) **Section 406 on tolerances for poisonous substances in food.**
  - (5) **Section 409 (c), (d), and (h) on food additive regulations.**
  - (6) **Section 501(b) on tests or methods of assay for drugs described in official compendia.**
  - (7) [Reserved]
  - (8) **Section 502(h) on regulations designating requirements for drugs liable to deterioration.**
  - (9) **Section 502(n) on prescription drug advertising regulations.**
  - (10) -(11) [Reserved]
  - (12) **Section 512(n)(5) on regulations for animal antibiotic drugs and certification requirements.**
  - (13) **Section 721 (b) and (c) on regulations for color additive listing and certification.**
  - (14) **Section 4(a) of the Fair Packaging and Labeling Act on food, drug, device, and cosmetic labeling.**
  - (15) [Section 5(c)](/cfr/21/5.md?p=c) of the Fair Packaging and Labeling Act on additional economic regulations for food, drugs, devices, and cosmetics.
  - (16) **Section 505 (d) and (e) on new drug applications.**
  - (17) **Section 512 (d), (e) and (m) (3) and (4) on new animal drug applications.**
  - (18) **Section 515(g) on device premarket approval applications and product development protocols.**
  - (19) **Section 351(a) of the Public Health Service Act on a biologics license for a biological product.**
  - (20) [Section 306](/cfr/21/306.md) on debarment, debarment period and considerations, termination of debarment under [section 306(d)(3)](/cfr/21/306.md?p=d-3), suspension, and termination of suspension.

## Notes

### Amendments

[44 FR 22323, Apr. 13, 1979, as amended at 54 FR 9034, Mar. 3, 1989; 58 FR 49190, Sept. 22, 1993; 60 FR 38626, July 27, 1995; 63 FR 26697, May 13, 1998; 64 FR 398, Jan. 5, 1999; 64 FR 56448, Oct. 20, 1999; 67 FR 4906, Feb. 1, 2002]

### Authority

Authority: 5 U.S.C. 551-558, 701-706; 15 U.S.C. 1451-1461; 21 U.S.C. 141-149, 321-397, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42 U.S.C. 201, 262, 263b, 264.

### Source

Source: 44 FR 22323, Apr. 13, 1979, unless otherwise noted.

### Amendments

[44 FR 22323, Apr. 13, 1979, as amended at 54 FR 9034, Mar. 3, 1989; 58 FR 49190, Sept. 22, 1993; 60 FR 38626, July 27, 1995; 63 FR 26697, May 13, 1998; 64 FR 398, Jan. 5, 1999; 64 FR 56448, Oct. 20, 1999; 67 FR 4906, Feb. 1, 2002]