Document ID: FDA-2009-N-0083-0001
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals
Posted Date: 2009-03-06T05:00Z

[Federal Register: March 6, 2009 (Volume 74, Number 43)]
[Notices]               
[Page 9822-9823]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06mr09-44]                         

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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