[Federal Register Volume 70, Number 89 (Tuesday, May 10, 2005)]
[Notices]
[Pages 24603-24605]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-9328]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005N-0012]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Allergen Labeling of Food Products 
Consumer Preference Survey and Experimental Study on Allergen Labeling 
of Food Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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 June 9, 
2005.

ADDRESSES: OMB is still experiencing significant delays in the regular 
mail, including first class and express mail, and messenger deliveries 
are not being accepted. 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: Fumie 
Yokota, Desk Officer for FDA, FAX: 202-395-6974.

FOR FURTHER INFORMATION CONTACT: Peggy Robbins, Office of Management 
Programs (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.

Allergen Labeling of Food Products Consumer Preference Survey

    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 a consumer survey about allergen labeling of food 
products under this authority. The Allergen Labeling of Food Products 
Consumer Preference Survey will collect information (see table 1 of 
this document) to gauge the impact of certain changes to the food label 
with respect to information about allergenic ingredients. This data 
collection is needed to satisfy some of the requirements of the Food 
Allergen Labeling and Consumer Protection Act (FALCPA) (Public Law 108-
282, title II, section 204.4), including the requirement that FDA 
provide data on consumer preferences in a report to Congress. In 
particular, section 204.4 of the FALCPA asks FDA to describe in the 
report ``* * *how consumers with food allergies or the caretakers of 
consumers would prefer that information about the risk of cross-contact 
be communicated on food labels as determined by using appropriate 
survey mechanisms.'' In addition, the survey will address other issues 
pertinent to allergen labeling changes mandated by the FALCPA. The data 
will be collected by means of a pool of people who will be screened 
(through self-report) for food allergy, and food allergy caregiver 
status. A balanced sample of 1,000 will be selected. Participation in 
the survey is voluntary.

Experimental Study on Allergen Labeling of Food Products

    As previously stated, under section 903(b)(2) of the act, 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 allergen labeling of food products under this authority. 
The Experimental Study on Allergen Labeling of Food Products will 
collect information (see table 2 of this document) to gauge the impact 
of certain changes to the food label with respect to information about 
allergenic ingredients. This data collection is needed to satisfy some 
of the requirements of the FALCPA, including the requirement that FDA 
provide data on consumer preferences with regard to allergen labeling 
in a report to Congress. In particular, section 204.4 of the FALCPA 
asks FDA to describe in the report ``* * *how consumers with food 
allergies or the caretakers of consumers would prefer that information 
about the risk of cross-contact be communicated on food labels as 
determined by using appropriate survey mechanisms.'' The allergen 
labeling experiment will supplement data collected by the Allergen 
Labeling of Food Products Consumer Preference Survey. In addition, the 
experiment will address other issues pertinent to allergen labeling 
changes mandated by the FALCPA. The experimental study data will be 
collected using an Internet panel of people who will be screened 
(through self-report) for food allergy, and food allergy caregiver 
status. Participation in the allergen experimental study is voluntary.
    In the Federal Register of January 26, 2005 (70 FR 3711), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. FDA received two comments, both from the same 
consortium of food allergy interested organizations: The American 
Academy of Allergy, Asthma & Immunology (AAAAI); the American College 
of Allergy, Asthma & Immunology (ACAAI); and The Food Allergy & 
Anaphylaxis Network (FAAN). The comments were identical and are 
addressed in the following paragraphs.
    The comments applauded FDA's goals for the research. The comments 
suggested that to improve the quality of the study and analysis, the 
agency should do the following: (1) Consider using FAAN's membership 
rolls to draw the samples, (2) screen the sampling frame to maximize 
the likelihood of recruiting truly food allergic individuals, (3) 
acknowledge that some households have multiple individuals who are food 
allergic, (4) recognize that some individuals do not have Internet 
access, (5) consider using advisory labeling that is currently found in 
the marketplace, and (6) collaborate closely with appropriate 
representatives from their organizations.
    The agency has considered the offer to use FAAN's membership rolls 
to draw the study samples and has determined that the high likelihood 
of bias would render results not generalizable. The agency does not 
agree that using FAAN's membership rolls will yield a better sample 
than can be acquired by using established Internet panels.
    FDA will utilize two consumer Internet panels to collect data for 
this research. One of the advantages to using Internet panels is the 
small ratio between the cost of the research and the

[[Page 24604]]

quality of the data collected. Another advantage is the minimal amount 
of field time needed to collect the information. This is an important 
consideration because of the FALCPA requirements for providing the 
informational report to Congress. A potential disadvantage of using 
Internet panels for data collection is the risk that the Internet 
panels' constituency may not adequately represent the general 
population, lessening its potential to provide generalizable data. A 
description of each panel follows.
    The Allergen Labeling of Food Products Consumer Preference Survey 
will utilize Knowledge Network's (a private research firm) Web-enabled 
panel. Knowledge Network's panel consists of 40,000 households who have 
agreed to participate in research studies conducted through the 
Internet. Knowledge Network's Web-enabled panel was constructed using 
random digit dialing procedures rendering samples drawn from them 
generalizable to the general population. Both Internet and Noninternet 
users were recruited. Both groups received equipment that allows them 
to participate in research via the Internet.
    The sample for the Experimental Study on Allergen Labeling of Food 
Products is Synovate, Inc.'s (a private research firm) Internet panel. 
Synovate's panel consists of 500,000 households who have agreed to 
participate in research studies conducted through the Internet. This 
panel was not constructed using random digit dialing procedures but 
rather by recruiting through multiple media. The panel was designed to 
closely match the general population on major demographic 
characteristics.
    The agency agrees that it is important to implement rigorous 
screening requirements in order to obtain samples of truly food 
allergic individuals. Many people believe that they have a food allergy 
when, in fact, they have an intolerance to a particular food or they 
have celiac disease. While these two conditions can produce symptoms 
that are similar to those sometimes seen with food allergies, the 
physiological mechanisms producing the reactions are entirely 
different. The agency has designed a screener that all panel members 
will receive in which they would be asked first whether or not they 
have a food allergy or if they regularly prepare food for someone with 
a food allergy, and then whether or not they have been medically 
diagnosed as food allergic. Then they are asked to state which 
diagnosis method was used.
    The agency agrees that some households have multiple members who 
are food allergic. As described previously in the discussion on the 
screener, Internet panel members are asked whether or not they, or 
someone for whom they regularly prepare food, has a food allergy. The 
reason we made the ``prepare food for someone with a food allergy'' 
distinction is to be able to categorize the respondent as a caregiver 
to someone with a food allergy. It is important to point out that the 
study will also recruit individuals who do not meet the criteria for 
food-allergic individual or caregiver. The nonfood allergic group will 
be analyzed separately from the food allergic group. The agency 
believes it is important to acknowledge that the population of food 
allergic individuals is not static and that at any time someone can 
become a member. These individuals must be able to immediately use the 
food label to determine whether or not it is safe for them to consume 
the food.
    The agency agrees that some individuals do not have access to the 
Internet. As discussed in the previous paragraphs, the Internet panel 
that will be used to draw the survey sample was constructed using 
random digit dialing procedures, and those without Internet access were 
supplied with equipment which allows them to access the Internet and to 
participate in consumer research.
    The agency agrees that it is important to use advisory labeling 
that is currently found in the marketplace. The agency has used the 
FAAN list of advisory statements and another list created by an 
informal market survey, and has classified the statements into 
groupings of similar statements. The statements that appear most often 
in each of the groupings were chosen for analysis in the study.
    The agency agrees that for the research to be of the highest 
quality and utility, collaboration with appropriate representatives 
from AAAAI, ACAAI, and FAAN is important and has already implemented 
this collaboration.
    FDA estimates the burden of the Allergen Labeling of Food Products 
Consumer Preference Survey collection of information as follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                             Number of        Annual Frequency  per       Total Annual
               Activity                     Respondents              Response              Responses            Hours per  Response        Total Hours
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Screener                                            500,000                      1                500,000                0.0055                   2,750
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Pretest                                                  30                      1                     30                0.167                        5
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Survey                                                1,000                      1                  1,000                0.167                      167
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Total                                                                                                                                             2,922
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

    FDA's burden estimate is based on prior experience with consumer 
surveys very similar to this proposed study.
    FDA estimates the burden of the Experimental Study on Allergen 
Labeling of Food Products collection of information as follows:

                                                     Table 2.--Estimated Annual Reporting Burden\1\
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                                             Number of        Annual Frequency  per       Total Annual
               Activity                     Respondents              Response              Responses            Hours per  Response        Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Screener                                             40,000                      1                 40,000                0.0055                     220
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[[Page 24605]]

 
Pretest                                                  30                      1                     30                0.167                        5
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Experiment                                            4,000                      1                  4,000                0.167                      668
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Total                                                                                                                                               893
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

    FDA's burden estimate is based on prior experience with Internet 
panel experiments similar to the study proposed here.

    Dated: May 4, 2005.
Jeffery Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-9328 Filed 5-9-05; 8:45 am]
BILLING CODE 4160-01-S