[Federal Register Volume 71, Number 69 (Tuesday, April 11, 2006)]
[Notices]
[Pages 18338-18339]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-5219]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006N-0130]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Food Labeling; Trans Fatty Acids in Nutrition Labeling

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on the information collection 
requirements of FDA's regulations requiring that trans fatty acids be 
declared in the Nutrition Facts panel of conventional foods and dietary 
supplements on a separate line without a percent Daily Value (%DV).

DATES: Submit written or electronic comments on the collection of 
information by June 12, 2006.

ADDRESSES: Submit electronic comments on the collection of information 
to: http://www.fda.gov/dockets/ecomments. Submit written comments on 
the collection of information to the Division of Dockets Management 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

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: Under the PRA (44 U.S.C. 3501-3520), Federal 
agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

[[Page 18339]]

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 (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 dietary 
supplements on a separate line immediately under the line for the 
declaration of saturated fat.
    Description of Respondents: Persons and businesses, including small 
businesses.
    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           Response         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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Totals                                                                                                                        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: April 3, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-5219 Filed 4-10-06; 8:45 am]
BILLING CODE 4160-01-S