[Federal Register Volume 76, Number 49 (Monday, March 14, 2011)]
[Notices]
[Pages 13626-13629]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-5736]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0129]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Comparing Nutrition Knowledge, Attitude, and Behavior 
Among English-Dominant Hispanics, Spanish-Dominant Hispanics, and Other 
Consumers

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 and 
to allow 60 days for public comment in response to the notice. This 
notice solicits comments on a study entitled ``Comparing Nutrition 
Knowledge, Attitude, and Behavior Among English-Dominant Hispanics, 
Spanish-dominant Hispanics, and Other Consumers.''

DATES: Submit either electronic or written comments on the collection 
of information by May 13, 2011.

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: Denver Presley, Office of Information 
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, 
Rockville, MD 20850, 301-796-3793.

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

[[Page 13627]]

of automated collection techniques, when appropriate, and other forms 
of information technology.

Comparing Nutrition Knowledge, Attitude, and Behavior Among English-
Dominant Hispanics, Spanish-Dominant Hispanics, and Other Consumers--
(OMB Control Number 0910-NEW)

I. Background

    Recent estimates suggest that Hispanics (defined as those who 
identify themselves as of Hispanic or Latino origin) are the largest 
and fastest growing minority group in the nation; the proportion of the 
U.S. population that was Hispanic was 14 percent in 2005 and is 
projected to increase to 29 percent in 2050 (Ref. 1).
    Data from the Centers for Disease Control and Prevention (CDC) 
indicate that, in 2005 and 2006, 34.3 percent and 32.7 percent of the 
U.S. adult population are obese and overweight, respectively (Ref. 1). 
According to CDC, Hispanics had 21 percent higher obesity prevalence 
than Whites in 2008 (Ref. 2). CDC data also indicate variations in 
prevalence of obesity among adults of different race-gender groups; for 
example, during 2006 through 2008, non-Hispanic Blacks had the greatest 
prevalence of obesity (35.7 percent), followed by Hispanics (28.7 
percent), and non-Hispanic Whites (23.7 percent); non-Hispanic Black 
women had the greatest prevalence (39.2 percent), followed by non-
Hispanic Black men (31.6 percent), Hispanic women (29.4 percent), 
Hispanic men (27.8 percent), non-Hispanic White men (25.4 percent), and 
non-Hispanic White women (21.8 percent) (Ref. 2).
    While some Hispanics living in the United States use the English 
language exclusively or more often than Spanish (English-dominant 
Hispanics), other U.S. Hispanics predominantly use the Spanish language 
in their daily lives (Spanish-dominant Hispanics) (Ref. 4). Since most 
U.S. food labels are in English, Spanish-dominant Hispanics' 
understanding and use of food labels may differ from that of English-
dominant Hispanics and of non-Hispanics who use English exclusively. In 
addition, both English-dominant Hispanics and Spanish-dominant 
Hispanics may have different awareness, perceptions, and behaviors than 
English-speaking non-Hispanics on issues of health, nutrition, and food 
consumption (Refs. 5 through 9).
    Existing research suggests that, in addition to language and other 
demographic differences, acculturation is an important factor 
associated with individual differences in dietary and public health 
related perceptions, attitudes, and behaviors among Hispanics. 
Acculturation is defined as the change in behavior and values by 
immigrants when they come in contact with a new group, nation, or 
culture (Ref. 10). Immigrants may possess different degrees of 
acculturation depending on the time of migration and other factors, 
such as the dominant culture of the neighborhoods where they live and 
work and type of education received (Refs. 11 and 12). Hence, variation 
in the degree of acculturation can lead to differences in lifestyle and 
behaviors, including behaviors related to dietary choices and to use 
and understanding of nutrition information on food labels, because of 
English proficiency and degree of assimilation into the values, 
lifestyles, and diets prevalent in this country. The existing research 
has shown the influence of acculturation on Hispanics' perceptions, 
attitudes, and behaviors relating to public health factors including 
dietary practices, nutrition, the health practices of pregnant women, 
obesity, coronary heart disease, Type 2 diabetes, alcohol consumption, 
and smoking behavior (for example, Refs. 11 and 13 through 22).
    FDA needs an understanding of how different population groups 
perceive and behave in terms of food label understanding and use, 
nutrition, and health to inform possible measures that the Agency may 
take to help consumers make informed dietary choices. FDA is aware of 
no consumer research on a nationwide level of the impact of language 
and acculturation on Hispanics' dietary choices and label use. This 
study is intended to provide answers to research questions such as 
whether and how much Spanish-dominant Hispanics, English-dominant 
Hispanics, and English-speaking non-Hispanics differ in their 
knowledge, attitude, and behavior toward food label use, nutrition, and 
health among three population groups and the role that demographic and 
other factors may play in any differences.
    The proposed study will use a Web-based survey to collect 
information from 2,400 adult members in online consumer panels 
maintained by a contractor. The study plans to randomly select 800 
members into each of three groups: Spanish-dominant Hispanics, English-
dominant Hispanics, and English-speaking non-Hispanics. Either an 
English or a Spanish questionnaire will be used, as appropriate. The 
study plans to include topics such as: (1) Nutrition and health; (2) 
use and understanding of food labels and labeling information; (3) 
degree of capacity to understand and use health information; and (4) 
levels of acculturation among Hispanic respondents as measured by a 
Hispanic acculturation scale that is widely used in social science 
research (Ref. 23). To help understand the data, the study will also 
collect information on participants' background, including, but not 
limited to, health status and demographic characteristics, such as age, 
gender, education, and income.
    The study is part of the Agency's continuing effort to enable 
consumers to make informed dietary choices and construct healthful 
diets. The results of the study will not be used to develop population 
estimates. The results of the study will be used for informing possible 
measures that the Agency may take to help consumers make informed 
dietary choices.
    To help design and refine the questionnaire, we plan to conduct 
cognitive interviews by screening 72 adult panelists in order to obtain 
9 participants in the interviews. Each screening is expected to take 5 
minutes (0.083 hour) and each cognitive interview is expected to take 
0.5 hour. The total for cognitive interview activities is 11 hours (6 
hours + 5 hours). Subsequently, we plan to conduct two waves of 
pretests of the questionnaire before it is administered in the study. 
We expect that 960 invitations, each taking 2 minutes (0.033 hour), 
will need to be sent to adult members of the online consumer panels to 
have 180 of them complete a 15-minute (0.25 hour) pretest. The total 
for the pretest activities is 77 hours (32 hours + 45 hours). For the 
survey, we estimate that 19,200 invitations, each taking 2 minutes 
(0.033 hour) to complete, will need to be sent to adult members of the 
online consumer panels to have 2400 of them complete a 15-minute (0.25 
hour) questionnaire. The total for the survey activities is 1,234 hours 
(634 hours + 600 hours). Thus, the total estimated burden is 1,322 
hours. FDA's burden estimate is based on prior experience with research 
that is similar to this proposed study.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 13628]]



                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                      Annual
        Portion of study             Number of     frequency per   Total annual      Hours per      Total hours
                                    respondents      response        responses       response
----------------------------------------------------------------------------------------------------------------
Cognitive interview screener....              72               1              72           0.083               6
Cognitive interview.............               9               1               9             0.5               5
Pretest invitation..............             960               1             960           0.033              32
Pretest.........................             180               1             180            0.25              45
Survey invitation...............          19,200               1          19,200           0.033             634
Survey..........................           2,400               1           2,400            0.25             600
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    Total.......................  ..............  ..............  ..............  ..............           1,322
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

II. References

    The following references have been placed on display in the 
Division of Dockets Management (see ADDRESSES) and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday. 
(FDA has verified the Web site addresses, but is not responsible for 
any subsequent changes to the Web site after this document publishes in 
the Federal Register.)
    1. CDC, ``Prevalence of Overweight, Obesity, and Extreme Obesity 
Among Adults: United States, Trends 1976-80 Through 2005-2006,'' 
available at http://www.cdc.gov/nchs/data/hestat/overweight/overweight_adult.pdf, December 2008.
    2. CDC, ``Differences in Prevalence of Obesity Among Black, White, 
and Hispanic Adults--United States, 2006-2008, ``Morbidity and 
Mortality Weekly Report, 58(27): 740-744, available at http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5827a2.htm, July 17, 2009.
    3. Passel, J.S. and C. D'Vera, ``U.S. Population Projections: 2005-
2050,'' Pew Research Center, Washington, DC, available at http://pewhispanic.org/files/reports/85.pdf, February 11, 2008.
    4. CDC, ``Health Disparities Experienced by Hispanics--United 
States,'' Morbidity and Mortality Weekly Report, 53(40): 935-7, 
available at http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5340a1.htm, 
October 15, 2004.
    5. National Heart, Lung and Blood Institute, ``Epidemiologic 
Research in Hispanic Populations: Opportunities, Barriers and 
Solutions,'' available at http://www.nhlbi.nih.gov/meetings/workshops/hispanic.htm, December 3, 2003.
    6. Lopez, M.H. and P. Taylor, ``Latinos and the 2010 Census: The 
Foreign Born Are Most Positive,'' Pew Research Center, Washington, DC, 
available at http://pewhispanic.org/files/reports/121.pdf, April 10, 
2010.
    7. Information Resources, INC., ``Times & Trends: Hispanic 
Consumers--Capturing CPG Market Potential,'' available at http://www.symphonyiri.com/portals/0/articlePdfs/TT_April_2008_Hispanic_Consumers.pdf, April 2008.
    8. Yang, S., M.G. Leff, D. McTague, et al., ``Multistate 
Surveillance for Food-Handling, Preparation, and Consumption Behaviors 
Associated With Foodborne Diseases: 1995 and 1996 Behavioral Risk 
Factor Surveillance Systems Food-Safety Questions,'' Morbidity and 
Mortality Weekly Report, 47(SS-4): 33-54, available at http://www.cdc.gov/mmwr/preview/mmwrhtml/00054714.htm, September 11, 1998.
    9. Lin, C.-T. J. and S.T. Yen, ``Knowledge of Dietary Fats Among 
U.S. Consumers,'' Journal of the American Dietetic Association, 110(4): 
613-8, April 2010.
    10. Marin, G., F. Sabogal, B.V. Marin, et al., ``Development of a 
Short Acculturation Scale for Hispanics,'' Hispanic Journal of 
Behavioral Sciences, 9(2): 183-205, 1987.
    11. Satia-About, J., R.E. Patterson, M.L. Neuhouser, et al., 
``Dietary Acculturation: Applications to Nutrition Research and 
Dietetics,'' Journal of the American Dietetic Association, 102(8): 
1105-1118, August 2002.
    12. Lin, H., O.I. Bermudez, and K.L. Tucker, ``Dietary Patterns of 
Hispanic Elders Are Associated With Acculturation and Obesity,'' 
Journal of Nutrition, 133: 3651-3657, 2003.
    13. Otero-Sabogal, R., F. Sabogal, E.J. P[eacute]rez-Stable, et 
al., ``Dietary Practices, Alcohol Consumption, and Smoking Behavior: 
Ethnic, Sex, and Acculturation Differences,'' Journal of National 
Cancer Institute Monograph, 18: 73-82, 1995.
    14. Lara, M., C. Gamboa, M.I. Kahramanian, et al., ``Acculturation 
and Latino Health in the United States: A Review of the Literature and 
Its Sociopolitical Context,'' Annual Review of Public Health 26: 367-
397. 2005.
    15. Winkleby, M.A., S.P. Fortmann, and B. Rockhill, ``Health-
Related Risk Factors in a Sample of Hispanics and Whites Matched on 
Sociodemographic Characteristics: The Stanford Five-City Project.'' 
American Journal of Epidemiology, 137(12): 1365-75, June 15, 1993.
    16. Byrd, T.L, H. Balcazar, and R.A. Hummer,'' Acculturation and 
Breast-Feeding Intention and Practice in Hispanic Women on the U.S.-
Mexico Border,'' Ethnicity & Disease 11(1): 72-79, 2001.
    17. Cobas, J.A., H. Balcazar, M.B. Benin, et al., ``Acculturation 
and Low-Birthweight Infants Among Latino Women: a Reanalysis of the 
Hispanic Health and Nutrition Examination Survey Data With Structural 
Equation Models,'' American Journal of Public Health, 86(3): 394-96, 
1996.
    18. Dixon, L.B., J. Sundquist, and M. Winkleby, ``Differences in 
Energy, Nutrient, and Food Intakes in a US Sample of Mexican-American 
Women and Men: Findings from the Third National Health and Nutrition 
Examination Survey,'' 1988-1994, American Journal of Epidemiology, 
152(6): 548-57, 2000.
    19. Khan, L.K., J. Sobal, and R. Martorell, ``Acculturation, 
Socioeconomic Status, and Obesity in Mexican Americans, Cuban 
Americans, and Puerto Ricans,'' International Journal of Obesity, 
21(2): 91-96, 1997.
    20. Markides, K.S., D.J. Lee, and L.A. Ray, ``Acculturation and 
Hypertension in Mexican Americans. Ethnicity & Disease,'' 3:70-74, 
1993.
    21. Stern, M.P., C. Gonzalez, B.D. Mitchell, et al., ``Genetic and 
Environmental Determinants of Type II Diabetes in Mexico City and San 
Antonio. Diabetes,'' 41(4): 484-92, 1992.
    22. Sundquist, J., and M.A. Winkleby, ``Cardiovascular Risk Factors 
in Mexican American Adults: a Transcultural Analysis of National Health 
and Nutrition Examination Survey III, 1988-1994,'' American Journal of 
Public Health, 89(5): 723-30, 1999.
    23. Thomson, M.D., and L. Hoffman-Goetz, ``Defining and Measuring

[[Page 13629]]

Acculturation: A Systematic Review of Public Health Studies With 
Hispanic Population in the United States,'' Social Science & Medicine, 
69: 983-991, 2009.

    Dated: March 4, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-5736 Filed 3-11-11; 8:45 am]
BILLING CODE 4160-01-P