Source: https://www.federalregister.gov/documents/2007/05/14/E7-9219/agency-information-collection-activities-submission-for-office-of-management-and-budget-review
Timestamp: 2018-05-20 12:25:44
Document Index: 516075063

Matched Legal Cases: ['arts 101', 'arts 101', 'arts 101', '§\u2009101', '§\u2009101', '§\u2009101', '§\u2009101', '§\u2009101', 'art\n101', 'art 102', 'art 104', 'art 102', 'art 104', 'art 105', 'art 104']

Fax written comments on the collection of information by June 13, 2007.
72 FR 27135
27135-27138 (4 pages)
Docket No. 2007N-0053
E7-9219
Food Labeling Regulations (OMB Control Number 0910-0381)—Extension
https://www.federalregister.gov/d/E7-9219 https://www.federalregister.gov/d/E7-9219
To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-6974. All comments should be identified with the OMB control number 0910-0381. Also include the FDA docket number found in brackets in the heading of this document.
FDA regulations require food producers to disclose to consumers and others specific information about themselves or their products on the label or labeling of their products. Related regulations require that food producers retain records establishing the basis for the information contained in the label or labeling of their products and provide those records to regulatory Start Printed Page 27136officials. Finally, certain regulations provide for the submission of food labeling petitions to FDA. FDA's food labeling regulations under parts 101, 102, 104, and 105 (21 CFR parts 101, 102, 104, and 105) were issued under the authority of sections 4, 5, and 6 of the Fair Packaging and Labeling Act (the FPLA) (15 U.S.C. 1453, 1454, and 1455) and under sections 201, 301, 402, 403, 409, 411, 701, and 721 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 321, 331, 342, 343, 348, 350, 371, and 379e). Most of these regulations derive from section 403 of the act, which provides that a food product shall be deemed to be misbranded if, among other things, its label or labeling fails to bear certain required information concerning the food product, is false or misleading in any particular, or bears certain types of unauthorized claims. The disclosure requirements and other collections of information in the regulations in parts 101, 102, 104, and 105 are necessary to ensure that food products produced or sold in the United States are in compliance with the labeling provisions of the act and the FPLA.
Section 101.3 of FDA's food labeling regulations requires that the label of a food product in packaged form bear a statement of identity (i.e., the name of the product), including, as appropriate, the form of the food or the name of the food imitated. Section 101.4 prescribes requirements for the declaration of ingredients on the label or labeling of food products in packaged form. Section 101.5 requires that the label of a food product in packaged form specify the name and place of business of the manufacturer, packer, or distributor and, if the food producer is not the manufacturer of the food product, its connection with the food product. Section 101.9 requires that nutrition information be provided for all food products intended for human consumption and offered for sale, unless an exemption in § 101.9(j) applies to the product. Section 101.9(g)(9) also provides for the submission to FDA of requests for alternative approaches to nutrition labeling. Finally, § 101.9(j)(18) provides for the submission to FDA of notices from firms claiming the small business exemption from nutrition labeling.
Section 101.14(d)(2) and (d)(3) provides for the disclosure of nutrition information in accordance with § 101.9 and, under some circumstances, certain other information as a condition for making a health claim for a food product. Section 101.15 provides that, if the label of a food product contains any representation in a foreign language, all words, statements, and other information required by or under authority of the act to appear on the label shall appear thereon in both the foreign language and in English. Section 101.22 contains labeling requirements for the disclosure of spices, flavorings, colorings, and chemical preservatives in food products. Section 101.22(i)(4) sets forth reporting and recordkeeping requirements pertaining to certifications for flavors designated as containing no artificial flavor. Section 101.30 specifies the conditions under which a beverage that purports to contain any fruit or vegetable juice must declare the percentage of juice present in the beverage and the manner in which the declaration is to be made. Section 102.33 specifies the common or usual name for beverages that contain fruit or vegetable juice.
Section 101.100(d) provides that any agreement that forms the basis for an exemption from the labeling requirements of section 403(c), (e), (g), (h), (i), (k), and (q) of the act be in Start Printed Page 27137writing and that a copy of the agreement be made available to FDA upon request. Section 101.100 also contains reporting and disclosure requirements as conditions for claiming certain labeling exemptions (e.g., § 101.100(h)).
Section 101.105 specifies requirements for the declaration of the net quantity of contents on the label of a food in packaged form and prescribes conditions under which a food whose label does not accurately reflect the actual quantity of contents may be sold, with appropriate disclosures, to an institution operated by Federal, State, or local government. Section 101.108 provides for the submission to FDA of a written proposal requesting a temporary exemption from certain requirements of §§ 101.9 and 105.66 for the purpose of conducting food labeling experiments with FDA's authorization.
In the Federal Register of February 27, 2007 (72 FR 8744), FDA published a 60-day notice requesting public comment on the information collection provisions. FDA received one comment that was outside the scope of the request for comments.
21 CFR Section/Part
101.3, 101.22, part 102, and part 104 25,000 1.03 25,750 .5 12,875 0
101.4, 101.22, 101.100, part 102, part 104, and part 105 25,000 1.03 25,750 1 25,750 0
101.5 25,000 1.03 25,750 0.25 6,438 0
101.9, 101.13(n), 101.14(d)(3), 101.62, and part 104 25,000 1.03 25,750 4 103,000 0
101.10 300,000 1.5 450,000 0.25 112,500 0
101.12(b) 29 2.3 67 1 67 0
101.12(h) 5 1 5 80 400 $533,600
101.13(d)(1) and 101.67 200 1 200 1 200 0
101.13(j)(2), 101.13(k), 101.54, 101.56, 101.60, 101.61, and 101.62 5,000 1 5,000 1 5,000 0
101.13(q)(5) 300,000 1.5 450,000 0.75 337,500 0
101.14(d)(2) 300,000 1.5 450,000 0.75 337,500 0
101.30 and 102.33 1,500 5 7,500 1 7,500 0
Start Printed Page 27138
101.36 300 40 12,000 4 48,000 0
101.42 and 101.45 1,000 1 1,000 0.5 500 0
101.70 5 1 5 80 400 $889,332
101.105 and 101.100(h) 25,000 1.03 25,750 0.5 12,875 0
101.108 0 0 40 0 0
Total 1,109,833 $1,422,932
[FR Doc. E7-9219 Filed 5-11-07; 8:45 am]