21 CFR 1.1370 - What must be included in a petition requesting modified requirements or an exemption from the requirements?

Regulations last checked for updates: Nov 23, 2024

Title 21 - Food and Drugs last revised: Nov 21, 2024

View all text of Subpart S [§ 1.1300 - § 1.1465]

§ 1.1370 - What must be included in a petition requesting modified requirements or an exemption from the requirements?

In addition to meeting the requirements on the content and format of a citizen petition in § 10.30 of this chapter, a petition requesting modified requirements or an exemption from the requirements of this subpart must:

(a) Specify the food or type of entity to which the modified requirements or exemption would apply;

(b) If the petition requests modified requirements, specify the proposed modifications to the requirements of this subpart; and

(c) Present information demonstrating why application of the requirements requested to be modified or from which exemption is requested is not necessary to protect the public health.

authority: 15 U.S.C. 1333,1453,1454,1455,4402; 19 U.S.C. 1490,1491; 21 U.S.C. 321,331,332,333,334,335a,342,343,350c,350d,350j,352,355,360b,360ccc,360ccc-1,360ccc-2,362,371,374,381,382,384a,387,387a,387c,393,and; 42 U.S.C. 216,241,243,262,264,271

source: 42 FR 15553, Mar. 22, 1977, unless otherwise noted.

cite as: 21 CFR 1.1370