[Federal Register: May 10, 2005 (Volume 70, Number 89)]
[Notices]
[Page 24603-24605]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10my05-92]
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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
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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