[Federal Register Volume 66, Number 40 (Wednesday, February 28, 2001)]
[Notices]
[Pages 12804-12805]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-4849]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N-1575]


Agency Information Collection Activities; Submission for OMB 
Review; Comment Request; Nutrition Labeling; Declaration of Caloric 
Amounts and Serving Sizes for Breath Mints

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

DATES: Submit written comments on the collection of information by 
March 30, 2001.

ADDRESSES: Submit written comments on the collection of information to 
the Office of Information and Regulatory Affairs, OMB, New Executive 
Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn: 
Wendy Taylor, Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT: Peggy Schlosburg, Office of 
Information Resources Management (HFA-250), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1223.

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.

Nutrition Labeling; Declaration of Caloric Amounts and Serving 
Sizes for Breath Mints--21 CFR 101.9(b) and (c)(1) (OMB Control 
Number 0910-0364)--Extension

    Section 403(q) of the Federal Food, Drug, and Cosmetic Act (the 
act) (21 U.S.C. 343(q)) requires that the label or labeling of a food 
bear nutrition information, including information on: (1) The serving 
size and number of servings per container, and (2) the number of 
calories present in a serving of the food. Under FDA's nutrition 
labeling regulations in Sec. 101.9(d)(3) (21 CFR 101.9(d)(3)), the 
nutrition facts panel of the food label must disclose the serving size 
of the food product and the number of servings in each package. Under 
Sec. 101.9(c)(1), the nutrition facts panel must disclose the number of 
calories present in a serving of the food.
    In the Federal Register of December 30, 1997 (62 FR 67775), FDA 
published a proposed rule to amend the nutrition labeling regulations 
by changing the label serving size for the product category ``Hard 
candies, breath mints'' to one unit. FDA proposed this change in 
response to a petition to provide a serving size for breath mints that 
more accurately reflects the amount customarily consumed per eating 
occasion. In a related issue, FDA also proposed to: (1) Modify the 
rounding rules for calories to allow the declaration of caloric amounts 
of less than 5 calories on the nutrition label, and (2) require that 
the number of calories declared on the nutrition label of a food 
product be consistent with any claims about caloric content that are 
made in its labeling. As a result of this proposed rule, manufacturers, 
packers, or distributors who make labeling claims that their products 
contain between 1 and 5 calories would be required to change the 
declaration of the amount of calories on the nutrition label. In 
addition, manufacturers of small breath mints would be required, under 
Sec. 101.9(b), to change the serving size and, under Sec. 101.9(c) and 
(d), to modify the amounts and daily values for nutrients listed in the 
nutrition label for their products. The proposal included burden 
estimates for the proposed changes and solicited public comment. In the 
interim, however, FDA is seeking an extension of OMB approval for the 
current regulations.
    In the Federal Register of December 5, 2000 (65 FR 75940), the 
agency requested comments on the proposed collection of information. No 
comments were received.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 12805]]



                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                 No. of       Annual frequency   Total annual      Hours per
              21 CFR Section                  respondents     per  response\2\     responses       response       Total operating costs     Total hours
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101.9(b) and (c)(1)                                4                  7.5            30               1                         $15,000        30
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Due to an inadvertent error, the ``Annual Frequency per Response'' column was omitted from the notice issued in the Federal Register of December 5,
  2000 (65 FR 75940). Table 1 of this document contains the inserted column.

    The proposed modification of the rules for the declaration of the 
amount of calories and the proposed change of the label serving size on 
the nutrition facts panel would result in a one-time burden created by 
the need for firms to revise their labels. In addition to changing the 
statement of calories and the serving sizes, firms would have to 
recalculate the number of servings per container and any nutrient 
amounts and daily values affected by the change in serving size. Of 
those breath mints for which FDA has information regarding the size of 
the product, there are 4 firms producing 5 brands of small breath 
mints, or approximately 30 distinct small breath mint labels. These are 
the only firms that would be affected by this proposed rule. FDA 
estimates that these firms would require an average of 1 hour per label 
to comply with the requirements of a final rule based on this proposal. 
For breath mint products, the average administrative, redesign, and 
inventory disposal costs for a labeling change of this type, with a 1-
year compliance period, would result in a one-time operating cost of 
$500 per label, or a total estimated operating cost of $15,000.

    Dated: February 22, 2001.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 01-4849 Filed 2-27-01; 8:45 am]
BILLING CODE 4160-01-S