[Federal Register Volume 74, Number 220 (Tuesday, November 17, 2009)]
[Pages 59188-59189]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-27512]

[[Page 59188]]



Food and Drug Administration

[Docket No. FDA-2009-N-0083]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Gluten-Free Labeling 
of Food Products Experimental Study

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


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

DATES: Fax written comments on the collection of information by 
December 17, 2009.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-6974, or e-mailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-NEW and 
title ``Gluten-Free Labeling of Food Products Experimental Study.'' 
Also include the FDA docket number found in brackets in the heading of 
this document.

Information Management (HFA-710), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-796-3793.

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.

Gluten-Free Labeling of Food Products Experimental Study--(OMB Control 
Number 0910-NEW)

    Under section 903(b)(2) of the Federal Food, Drug, and Cosmetic Act 
(the 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 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.
    In a 60-day Federal Register notice, which published on March 6, 
2009 (74 FR 9822), FDA stated that the data would 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. FDA will not utilize the membership list of a celiac 
disease special interest organization. Instead, FDA will obtain 
participants through the assistance of major celiac disease and 
research centers around the United States. Participation in the study 
is voluntary.
    Also in the March 6, 2009, sixty-day Federal Register notice, FDA 
requested public comment on the proposed information collection 
provisions. FDA received 34 letters in response to the notice, each 
containing 1 or more comments. The comments, and the agency's 
responses, are discussed in the following paragraphs. Some of the 
comments received were beyond the scope of the collection of 
information. Those comments are not addressed in this document.
    (Comment 1) Several comments cited the importance of doing the 
gluten-free study and commended FDA for doing it.
    (Response) FDA agrees that the study will help FDA learn how 
consumers react and respond to the gluten-free labeling options 
presented in the gluten-free labeling proposed rule (See 72 FR 2795, 
January 23, 2007).
    (Comment 2) One comment suggested using software tools such as 
surveymonkey.com to minimize the costs associated with creating online 
surveys. This comment also suggested using a survey program that 
allowed for both closed-ended (choose a response) and open-ended (write 
a response) response options.
    (Response) FDA agrees that using existing software to collect data 
online will minimize the costs. The contractor hired to collect the 
data has a long history of online data collection and has existing 
software for this type of data collection. This software allows for 
multiple types of questions and response options.
    (Comment 3) Several comments recommended that FDA expand the data 
collection method from using the Internet only to also include paper 
surveys. One comment said that computer access is difficult for people 
who live in rural areas. Another comment said that elderly people and 
those with lower incomes are less likely to have access to computers.
    (Response) FDA agrees that a paper version should be available for 
people who might have difficulties in accessing the internet. FDA plans 
to make a paper version available by providing a telephone number for 
potential respondents to call and request a paper version. The 
telephone number will be included in a flyer about the study FDA will 
disseminate to celiac disease treatment and research centers to post 
for patients to view.
    (Comment 4) One comment said that many children have access to 
computers only at school so they suggested that FDA offer a paper 
survey so that respondents can include children.
    (Response) FDA disagrees. The study is limited to adults age 18 and 
above. This age group includes individuals who regularly shop for and 
prepare foods. FDA acknowledges that children can shop for and prepare 
foods but the likelihood that they do is far less than their 
caregivers, who will be included in the study.
    (Comment 5) One comment recommended FDA to test gluten-free 
statements that say, ``Testing meets FDA standards for gluten'' and 
``Testing meets FDA standards of less than 20ppm of gluten present.''
    (Response) FDA disagrees with the comment. Section 206 of the Food 
Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) (Title 
II of Public Law No. 108-282) requires FDA to issue a rule to define 
and permit use of the term ``gluten-free'' on the labeling of foods. In 
the proposed rule (72 FR 2795), FDA proposed a regulation to define the 
term ``gluten-free'' and to establish uniform conditions for its use in 
the voluntary labeling of foods. FDA will not test these statements 
because they are not consistent with FALCPA or with our proposed rule.
     (Comment 6) One comment suggested having an open-ended question 
where respondents can describe the type of labeling that they believe 
is the best and most understandable.

[[Page 59189]]

    (Response) FDA agrees and will provide an open-ended question at 
the end of the questionnaire to allow respondents to comment on the 
study and to make suggestions for labeling preferences.
    (Comment 7) One comment asked that the questions be very clear.
    (Response) FDA agrees that it is important that the study questions 
be unambiguous. To achieve this goal, FDA will conduct cognitive 
interviews prior to administering the main study, in which a trained 
interviewer goes through the questionnaire with adults with celiac 
disease and discusses whether the questions are understandable and 
    (Comment 8) Several comments had recommendations for groups of 
people that should be included in the study. One comment said that the 
control group, the people for whom gluten poses no adverse health-
effects, should be comprised of individuals who are ``avid label 
readers,'' on the theory that their label-reading behavior would make 
them most like people who use label information to help them avoid 
gluten. One comment said it was essential to get participants who are 
in various stages of a gluten-free diet because labeling needs are 
different depending on how long one has been diagnosed with celiac 
disease. One comment said it was important to recruit participants from 
various ethnic and socio-economic backgrounds because these factors may 
have impacts on what people eat. One comment said the FDA should 
consider that many people who have celiac disease or gluten 
sensitivities also have other food intolerances and the survey should 
be constructed with these people in mind.
    (Response) FDA agrees that the control group should consist of 
respondents who frequently read the food label in making purchase 
decisions. FDA will identify and recruit such individuals by including 
a question in the study screener to gauge such efforts. FDA will also 
identify and recruit individuals who report in the study screener that 
they follow gluten free diets for reasons other than that they have 
celiac disease. FDA will include a question for individuals with celiac 
disease and for caregivers to such individuals that asks how long they 
have been diagnosed with celiac disease. FDA expects that individuals 
from various ethnic and socio-economic backgrounds will respond to the 
invitation to participate in the study. Working through major celiac 
disease and research centers around the United States will also help to 
reach a diverse population. FDA will include a question in the study 
asking individuals with celiac disease if they have other food 
intolerances or food allergies.
    (Comment 9) One comment suggested including natural food store 
owners in the study.
    (Response) FDA disagrees with the comment that natural food store 
owners should be included in the study. The study population in this 
research is consumers. Store owners may participate if they meet the 
study criteria.
    (Comment 10) One comment suggested that instead of recruiting 
participants from celiac disease special interest groups that might 
introduce interest-based biases, FDA should contact celiac disease and 
research centers to ask them to distribute the survey to their mailing 
    (Response) FDA agrees with the comment and has contacted major 
celiac disease and research centers around the United States to ask 
them to distribute an invitation to participate in the study to their 
mailing lists, if they have one, and to put up a flyer at their centers 
inviting patients to participate online or call to request a paper 
    (Comment 11) Several comments suggested making the survey available 
in more than one language.
    (Response) FDA disagrees. Although making the questionnaire 
available in more than one language increases public access, FDA plans 
to administer the study only in English because existing research and 
information on individuals with celiac disease and gluten-intolerances 
does not suggest that gluten-free labeling issues vary by culture.
    (Comment 12) One comment suggested that the survey results should 
be made available to the public.
    (Response) FDA agrees with the comment and will make the study 
results available when they are ready.
    FDA estimates the burden of this collection of information as 

                                                     Table 1.--Estimated Annual Reporting Burden\1\
                                                                         Annual Frequency      Total Annual
                  Questionnaire                    No. of  Respondents     per Response          Responses        Hours per  Response     Total Hours
Screener                                                        10,000                  1                10,000                0.0055                 55
Pretest                                                            140                  1                   140                  .167                 24
Experiment                                                       7,000                  1                 7,000                  .167              1,169
Total                                             ....................  .................  ....................  ....................              1,248
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    In the March 6, 2009, sixty-day notice, FDA estimated the total 
annual reporting burden to be 892 hours. FDA has made several changes 
to its burden estimate as reflected in table 1 of this document. The 
agency increased: (1) The number of screeners from 6,000 to 10,000 and 
(2) the number of completed questionnaires from 5,000 to 7,000.
    Approximately 10,000 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 55 hours. A pretest will be 
conducted with 140 respondents; we estimate that it will take a 
respondent 10 minutes (0.167 hours) to complete the pretest, for a 
total of 24 hours. Seven thousand (7,000) respondents 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 1,169 
hours. Thus, the total estimated annual reporting burden is 1,248 
hours. FDA's burden estimate is based on prior experience with consumer 
experiments that are similar to this proposed experiment.

    Dated: November 9, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-27512 Filed 11-16-09; 8:45 am]