[Federal Register Volume 71, Number 197 (Thursday, October 12, 2006)]
[Notices]
[Pages 60157-60158]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-16840]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006N-0130]


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.

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[[Page 60158]]

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: 202-395-6974.

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 Sec.  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 Sec.  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, Sec. Sec.  
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 Burden\1\
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                                               No. of       Annual Frequency     Total Annual        Hours per                          Total Operating
              21 CFR Section                 Respondents      per Response        Responses          Respondent        Total Hours           Costs
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101.9(c)(2)(ii)                                    10,490                 27            278,100                  2            556,200           $155,200
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101.36(b)(2)                                          910                 32             29,500                  2             59,000            $16,500
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Total                                                                                                                         615,200           $171,700
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\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 Sec. Sec.  
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 Sec. Sec.  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 Sec. Sec.  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.
[FR Doc. E6-16840 Filed 10-11-06; 8:45 am]
BILLING CODE 4160-01-S