[Federal Register Volume 74, Number 43 (Friday, March 6, 2009)]
[Notices]
[Pages 9822-9823]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-4766]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0083]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Gluten-Free Labeling of Food Products Experimental
Study
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 and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on a voluntary consumer study entitled
``Gluten-Free Labeling of Food Products Experimental Study.''
DATES: Submit written or electronic comments on the collection of
information by May 5, 2009.
ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. 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 Information
Management (HFA-710), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-796-3794.
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 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.
Gluten-Free Labeling of Food Products Experimental Study
Under section 903(b)(2) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 393(b)(2)), FDA is authorized to conduct research relating
to foods and to conduct educational and public information programs
relating to the safety of the nation's food supply. FDA is planning to
conduct an experimental study about gluten-free labeling of food
products. The Gluten-Free Labeling of Food Products Experimental Study
will collect information from both consumers who have celiac disease or
gluten intolerance and those who do not have either condition. The
purpose of the study is to gauge perceptions of characteristics related
to claims of ``gluten-free'' and allowed variants (e.g., ``free of
gluten,'' ``without gluten,'' ``no gluten''), in addition to other
types of statements (e.g., ``made in a gluten-free facility'' or ``not
made in a facility that processes gluten-containing foods'') on the
food label. The study will also
[[Page 9823]]
assess consumer understanding of ``gluten-free'' claims on foods that
are naturally free of gluten, and gauge consumer reaction to a product
carrying a gluten claim concurrently with a statement about the amount
of gluten the product contains.
The data will be collected over the Internet from samples derived
from two sources: (1) A membership list from a celiac disease special
interest organization and (2) an online consumer panel. Participation
in the study is voluntary.
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
Questionnaire Respondents per Response Responses Response Total Hours
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Screener 6,000 1 6,000 0.0055 33
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Pretest 140 1 140 .167 23.38
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Experiment 5,000 1 5,000 .167 835
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Total ................. .................... ................. ................. 891.38
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Approximately 6,000 respondents will be screened. We estimate that
it will take a respondent 20 seconds (0.0055 hours) to complete the
screening questions, for a total of 33 hours. A pretest will be
conducted with 140 participants; we estimate that it will take a
respondent 10 minutes (0.167 hours) to complete the pretest, for a
total of 23.38 hours. Five thousand adults will complete the
experiment. We estimate that it will take a respondent 10 minutes
(0.167 hours) to complete the entire experiment, for a total of 835
hours. Thus, the total estimated burden is 891.38 hours. FDA's burden
estimate is based on prior experience with consumer experiments that
are similar to this proposed experiment.
Dated: February 23, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-4766 Filed 3-5-09; 8:45 am]
BILLING CODE 4160-01-S