[Federal Register: April 11, 2006 (Volume 71, Number 69)]
[Notices]
[Page 18338-18339]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr11ap06-105]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per Total Operating
21 CFR Section Respondents per Response Responses Response Total Hours 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
--------------------------------------------------------------------------------------------------------------------------------------------------------
Totals 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 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