[Federal Register Volume 70, Number 16 (Wednesday, January 26, 2005)]
[Notices]
[Pages 3711-3712]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-1395]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005N-0012]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; 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 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, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on a voluntary consumer survey 
entitled ``Allergen Labeling of Food Products Consumer Preference 
Survey'' and an experimental study entitled ``Experimental Study on 
Allergen Labeling of Food Products.''

DATES: Submit written or electronic comments on the collection of 
information by March 28, 2005.

ADDRESSES: Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments. All comments should be identified with 
the docket number found in brackets in the heading of this document.

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: 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, including 
each proposed extension of an existing 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.

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 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.
    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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                        No. of        Annual Frequency      Total Annual        Hours per
  Questionnaire      Respondents        per Response         Responses           Response         Total Hours
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Screener                     35,000                1                35,000              .0055                193
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Pre-test                         30                1                    30               .167                  5
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[[Page 3712]]

 
Survey                        1,000                1                 1,000               .167                167
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Total                                                                                                        365
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\1\There are no capital costs or operating 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.

Experimental Study on Allergen Labeling of Food Products

    As previously above, 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 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 approximately 600,000 people who will be screened (through self-
report) for food allergy, and food allergy caregiver status. 
Participation in the allergen experimental study is voluntary.
    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\
----------------------------------------------------------------------------------------------------------------
                        No. of        Annual Frequency      Total Annual        Hours per
  Questionnaire      Respondents        per Response         Responses           Response         Total Hours
----------------------------------------------------------------------------------------------------------------
Screener                    600,000                1               600,000              .0028              1,680
----------------------------------------------------------------------------------------------------------------
Pre-test                         30                1                    30               .167                  5
----------------------------------------------------------------------------------------------------------------
Experiment                    9,000                1                 9,000               .167              1,503
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Total                                                                                                      3,188
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\1\There are no capital costs or operating 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: January 18, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-1395 Filed 1-25-05; 8:45 am]
BILLING CODE 4160-01-S