---
kind: "section"
citation: "21 C.F.R. § 1271.21"
title: "21"
number: "1271.21"
heading: "When do I register, submit an HCT/P list, and submit updates?"
url: "https://uscodex.org/cfr/21/1271.21"
---

# §1271.21. When do I register, submit an HCT/P list, and submit updates?

- (a) You must register and submit a list of every HCT/P that your establishment manufactures within 5 days after beginning operations or within 30 days of the effective date of this regulation, whichever is later.
- (b) You must update your establishment registration annually in December, except as required by [§ 1271.26](/cfr/21/1271.26.md). You may accomplish your annual registration in conjunction with updating your HCT/P list under [paragraph (c)](#c) of this section.
- (c)
- (i) If no change described in [§ 1271.25(c)](/cfr/21/1271.25.md?p=c) has occurred since you previously submitted an HCT/P list, you are not required to update your listing.
- (ii) If a change described in [§ 1271.25(c)](/cfr/21/1271.25.md?p=c) has occurred, you must update your HCT/P listing with the new information:

  (a) At the time of the change, or

  (b) Each June or December, whichever month occurs first after the change.


## Notes

### Amendments

[69 FR 68681, Nov. 24, 2004]

### Authority

Authority: 42 U.S.C. 216, 243, 263a, 264, 271.

### Source

Source: 66 FR 5466, Jan. 19, 2001, unless otherwise noted.

### Amendments

[69 FR 68681, Nov. 24, 2004]