Source: https://www.federalregister.gov/articles/2012/11/13/2012-27485/agency-information-collection-activities-proposed-collection-comment-request-food-additive-petitions
Timestamp: 2015-11-29 12:20:37
Document Index: 33340734

Matched Legal Cases: ['art 571', 'arts 501', '§ 571', 'art 501', '§ 570', '§ 571', '§ 571', '§ 571', '§ 570', '§ 570']

Federal Register | Agency Information Collection Activities; Proposed Collection; Comment Request; Food Additive Petitions and Investigational Food Additive Exemptions; Extension
-67656 (2 pages)
Document Number: 2012-27485
Shorter URL: https://federalregister.gov/a/2012-27485 Regulations.gov Docket Info
Table 1—Estimated Annual Reporting Burden1Food Additive Petitions
Table 2—Estimated Annual Reporting Burden1Investigation Food Additive Files
Food Additive Petitions and Investigational Food Additive Exemptions, 21 CFR 570.17 and 571 (OMB Control Number 0910-0546)—Extension Back to Top
Section 409(a) of the Federal Food, Drug and Cosmetic Act (FD Act) (21 U.S.C. 348(a)) provides that a food additive shall be deemed to be unsafe unless its use is permitted by a regulation which prescribes the condition(s) under which it may safely be used, or unless it is exempted by regulation for investigational use. Section 409(b) of the FD Act specifies the information that must be submitted by a petitioner in order to establish the safety of a food additive and to secure the issuance of a regulation permitting its use.
To implement the provisions of section 409 of the FD Act, procedural regulations have been issued under 21 CFR part 571. These procedural regulations are designed to specify more thoroughly the information that must be submitted to meet the requirement set down in broader terms by the FD Act. The regulations add no substantive requirements to those indicated in the FD Act, but attempt to explain these requirements and provide a standard format for submission to speed processing of the petition. Labeling requirements for food additives intended for animal consumption are also set forth in various regulations contained in parts 501, 573, and 579. The labeling regulations are considered by FDA to be cross-referenced to § 571.1, which is the subject of this same OMB clearance for food additive petitions.
To implement the provisions of section 409(j), regulations have been issued under 21 CFR 570.17. These regulations are designed to specify more thoroughly the information that must be submitted to meet the requirement set down in broad terms by the FD Act. Labeling requirements for investigational food additives are also set forth in various regulations contained in part 501. The labeling regulations are considered by FDA to be cross referenced to § 570.17, which is the subject of this same OMB clearance for investigational food additive files.
Table 1—Estimated Annual Reporting Burden1Food Additive Petitions Back to Top
571.1(c) Moderate Category
571.1(c) Complex Category
571.6 Amendment of Petition
§ 571.1(c) Moderate Category: For a food additive petition without complex chemistry, manufacturing, efficacy, or safety issues, the estimated time requirement per petition is approximately 3,000 hours. An average of 1 petition of this type is received on an annual basis, resulting in a burden of 3,000 hours.
§ 571.1(c) Complex Category: For a food additive petition with complex chemistry, manufacturing, efficacy, and/or safety issues, the estimated time requirement per petition is approximately 10,000 hours. An average of 1 petition of this type is received on an annual basis, resulting in a burden of 10,000 hours.
§ 571.6: For a food additive petition amendment, the estimated time requirement per petition is approximately 1,300 hours. An average of 4 petitions of this type is received on an annual basis, resulting in a burden of 5,200 hours.
Table 2—Estimated Annual Reporting Burden1Investigation Food Additive Files Back to Top
570.17 Moderate Category
570.17 Complex Category
§ 570.17 Moderate Category: For an investigational food additive file without complex chemistry, manufacturing, efficacy, or safety issues, the estimated time requirement per file is approximately 1,500 hours. An average of 9 files of this type are received on an annual basis, resulting in a burden of 13,500 hours.
§ 570.17 Complex Category: For an investigational food additive file with complex chemistry, manufacturing, efficacy, and/or safety issues, the estimated time requirement per file is approximately 5,000 hours. An average of 4 files of this type are received on an annual basis, resulting in a burden of 20,000 hours.