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 Department of Health and Human Services Food and Drug Administration [Docket No. FDA-2009-N-0345]
 AGENCY: Food and Drug Administration, HHS.
 ACTION: Notice.
 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 the Internet Survey on Barriers to Food Label Use.
 DATES: Submit written or electronic comments on the collection of information by October 23, 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: Daniel Gittleson, Office of Information Management (HFA-710), Food and Drug 
                        ( print page 42677)
                        Administration, 5600 Fishers Lane, Rockville, MD 20857, 
                        *Daniel.Gittleson@fda.hhs.gov*, 301-796-5156.


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. Internet Survey on Barriers to Food Label Use Previous FDA studies have examined the prevalence of food label use and the types of tasks food label users perform. Analyses of repeated survey data show a sharp decline in label use between 1994 and 2002. Much of the decline in label use occurred among young consumers, i.e., those younger than 35 years old. In 1994, approximately 13% of U.S. consumers reported “never” using the food label the first time they purchase a product, with no significant differences between various age groups. In 2002, the proportion of consumers reporting “never” using the food label the first time they purchase a product had increased to 19%, a significant increase over the 1994 percentage. In comparison, the proportion of consumers younger than 35 years old who reported “never” using the food label the first time they purchase a product had increased from 13% in 1994 to nearly 30% in 2002. Therefore, FDA is proposing to conduct an Internet survey to assess barriers to food label use by U.S. consumers. FDA conducts research and educational and public information programs relating to food safety under its broad statutory authority, set forth in section 903(b)(2) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 393(b)(2), to protect the public health by ensuring that foods are “safe, wholesome, sanitary, and properly labeled,” and in section 903(d)(2)(C) (21 U.S.C. 393(d)(2)(C)), to conduct research relating to foods, drugs, cosmetics and devices in carrying out the act. The study is part of an on-going effort by FDA to collect data concerning consumer perceptions, attitudes, and behaviors and their impacts on food label usage. The study, the Internet Survey on Barriers to Food Label Use, is a voluntary consumer survey. The purpose of the study is to explore possible explanations for food label use and non-use among U.S. consumers. In particular, the study will collect data from four groups of consumers: (1) those older than 35 years that report regularly using the food label; (2) those older than 35 years old that report infrequently using the food label; (3) those 35 years and younger that report regularly using the food label; (4) those 35 years and younger that report infrequently using the food label. The study goals are to: (1) identify attitudes and beliefs among consumers toward health, diet and label usage; (2) determine relationships between those attitudes and beliefs, as well as demographics, with food label use and non-use; and (3) evaluate the relative importance of these attitudes between consumers of various age groups to determine whether barriers to label use differ between younger consumers and older consumers. The information collected from the study is necessary to inform the agency's efforts to improve consumer understanding and use of the food label. The results of the study will not be used to develop population estimates. The Internet survey data will be collected using participants of an Internet panel of approximately 43,000 people. Participation in the experimental study is voluntary. FDA estimates the burden of this collection of information as follows: **Table 1.—Estimated Annual Reporting Burden1**
Portion of Study
No. of 
                             Respondents
Frequency per 
                             Response
Total Annual 
                             Responses
Hours per 
                             Response
Total HoursPre-test
60
1
60
0.167
10Screener
8,000
1
8,000
0.0083
66Survey
1,000
1
1,000
0.167
167Total

1
9,060

2431
                         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. Sixty (60) panel members will take part in a pre-test of the survey, estimated to last 10 minutes (0.167 hours), for a total of 10.02 hours, rounded to 10. Approximately 8,000 respondents will complete a screener to determine eligibility for participation in the study, estimated to take 30 seconds (0.0083 hours), for a total of 66.4 hours, rounded to 66 hours. One thousand (1,000) respondents will complete the full survey, estimated to last 10 minutes (0.167 hours), for a total of 167 hours. The total estimated burden is 243 hours. Dated: August 17, 2009. David Horowitz, Assistant Commissioner for Policy.


[FR Doc. E9-20248 Filed 8-21-09; 8:45 am] BILLING CODE 4160-01-S