CFR - Code of Federal Regulations Title 21

The information on this page is current as of Dec 22, 2023.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

[Code of Federal Regulations]

[Title 21, Volume 1]

[CITE: 21CFR1.1440]

TITLE 21--FOOD AND DRUGS

CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER A - GENERAL

PART 1 -- GENERAL ENFORCEMENT REGULATIONS

Subpart S - Additional Traceability Records for Certain Foods

Waivers

Sec. 1.1440 What process will FDA follow when waiving a requirement of this subpart on our own initiative?

(a) If FDA, on our own initiative, determines that a waiver of one or more requirements for an individual entity or type of entity is appropriate, we will publish a notice in the Federal Register setting forth the proposed waiver and the reasons for such waiver. The notice will establish a public docket so that interested persons may submit written comments on the proposal.

(b) After considering any comments timely submitted, we will publish a notice in the Federal Register stating whether we are granting the waiver (in whole or in part) and the reasons for our decision.

(c) Any waiver for a type of entity that FDA grants will become effective on the date that notice of the waiver is published in the Federal Register, unless otherwise stated in the notice.