E6-16840. Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food Labeling; Trans Fatty Acids in Nutrition Labeling

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

DATES:

Fax written comments on the collection of information by November 13, 2006.

ADDRESSES:

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: [phone].

FOR FURTHER INFORMATION CONTACT:

Jonna Capezzuto, Office of Management Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4659.

SUPPLEMENTARY INFORMATION:

In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.

Food Labeling; Trans Fatty Acids in Nutrition Labeling—21 CFR 101.9(C)(2)(ii) and 101.36(b)(2) (OMB Control Number 0910-0515)—Extension

Section 403(q) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 343(q)) establishes the requirements for nutrition labeling of foods. In particular, section 403(q)(1)(A) and 403(q)(1)(B) require that the label or labeling of a food bear nutrition information on the amount of nutrients present in a product. Section 403(q)(2) of the act permits FDA to require information about nutrients not specified in section 403(q)(1) if that additional information will assist consumers in maintaining healthy dietary practices. Section 403(q)(5)(F) of the act specifies the nutrition information that must be on the label or labeling of dietary supplements. Under these provisions of the act, FDA issued regulations in § 101.9(c)(2) (21 CFR 101.9(c)(2)) that require information on the amounts of fat and certain fatty acids in food products to be disclosed in the Nutrition Facts panel. Similarly, FDA issued regulations in § 101.36(b) (21 CFR 101.36(b)) that specify the nutrition information that must be on the label or labeling of dietary supplements. In particular, §§ 101.9(c)(2)(ii) and 101.36(b)(2) require that the amount of trans fatty acids present in a food, including dietary supplements, must be declared on the nutrition label of conventional foods, and for dietary supplements, on a separate line immediately under the line for the declaration of saturated fat.

Respondents are expected to be persons and businesses, including small businesses.

In the Federal Register of April 11, 2006 (71 FR 18338), FDA published a 60-day notice requesting public comment on the information collection provisions. One comment was received but unrelated to the information collection.

FDA estimates the burden of this collection of information as follows:

Table 1.—Estimated Annual Reporting Burden¹

21 CFR Section	No. of Respondents	Annual Frequency per Response	Total Annual Responses	Hours per Respondent	Total Hours	Total Operating Costs
101.9(c)(2)(ii)	10,490	27	278,100	2	556,200	$155,200
101.36(b)(2)	910	32	29,500	2	59,000	$16,500
Total					615,200	$171,700
1 There are no capital costs or maintenance costs associated with this collection of information.

FDA believes that the burden associated with the disclosure of trans fatty acid information on labels or in labeling food and dietary supplement products is largely a one-time burden created by the need for firms to revise the labels for those existing products that contain trans fatty acids.

FDA estimated that there were approximately 10,490 firms producing food products and 910 firms producing dietary supplement products that, because they contain trans fatty acids, were affected by §§ 101.9 and 101.36. The agency estimated that these firms needed to revise approximately 278,100 food labels and 29,500 dietary supplement labels, although only about 25 percent of these label changes would have to be made earlier than the firms planned. Because these firms were already disclosing information on total fat, saturated fat, and other significant nutrients on their product labels, based upon its knowledge of food and dietary supplement labeling, FDA estimated that firms would require less than 2 hours per product to comply with the nutrition labeling requirements of §§ 101.9 and 101.36.

Multiplying the total number of responses by the hours per response gives the total hours. FDA estimated operating costs by combining testing and relabeling costs ($44.9 million + $126.8 million). This total was then apportioned between §§ 101.9 and 101.36 according to the proportion of responses for each section. Based on the labeling cost model, FDA expected that, with a compliance period of over 2 years, 75 percent of firms will coordinate labeling revisions required by the trans fat final rule with other planned labeling changes for their products.

Dated: October 5, 2006.

Jeffrey Shuren,

Assistant Commissioner for Policy.