[Federal Register Volume 76, Number 163 (Tuesday, August 23, 2011)]
[Notices]
[Pages 52665-52667]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-21485]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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 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 
September 22, 2011.

ADDRESSES: 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: FDA Desk Officer, 
FAX: 202-395-7285, or e-mailed to [email protected]. All 
comments should be identified with the OMB control number 0910-New and 
title ``Comparing Nutrition Knowledge, Attitude, and Behavior Among 
English-Dominant Hispanics, Spanish-Dominant Hispanics, and Other 
Consumers.'' Also include the FDA 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: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

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. 2). 
According to CDC, Hispanics had 21 percent higher obesity prevalence 
than Whites in 2008 (Ref. 3). 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. 3).
    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

[[Page 52666]]

(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 8).
    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. 9). 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. 10 and 11). 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. 10 and 12 through 21).
    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. 22). 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 360 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 57 hours (12 hours + 45 hours). For the 
survey, we estimate that 4,800 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 2,400 of them complete a 15-minute (0.25 
hour) questionnaire. The total for the survey activities is 758 hours 
(158 hours + 600 hours). Thus, the total estimated burden is 826 hours. 
This estimate is 496 hours lower than the 1,322 hours published in the 
60-day notice and reflects 20 fewer hours for pretest invitation and 
476 fewer hours for survey invitation. Recent evidence available to the 
Agency suggests the study will not need to send as many invitations as 
originally estimated to achieve its target sample sizes in pretest and 
survey. FDA's burden estimate is based on prior experience with 
research that is similar to this proposed study.
    In the Federal Register of March 14, 2011 (76 FR 13626), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                  Table 1--Estimated Annual Reporting Burden 1
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                                                 Number of
          Activity               Number of     responses per   Total annual   Average burden per    Total hours
                                respondents     respondent       responses         response
----------------------------------------------------------------------------------------------------------------
Cognitive interview screener              72               1              72  0.083 (5 min.)....               6
Cognitive interview.........               9               1               9  0.5 (30 min.).....               5
Pretest invitation..........             360               1             360  0.033 (2 min.)....              12
Pretest.....................             180               1             180  0.25 (15 min.)....              45
Survey invitation...........           4,800               1           4,800  0.033 (2 min.)....             158
Survey......................           2,400               1           2,400  0.25 (15 min.)....             600
                             -----------------------------------------------------------------------------------
    Total...................  ..............  ..............  ..............  ..................             826
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1 There are no capital costs or operating and maintenance costs associated with this collection of information.


[[Page 52667]]

II. References

    The following references have been placed on display in the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852, 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. Passel, J.S. and C. D'Vera, ``U.S. Population Projections: 
2005-2050,'' Pew Research Center, Washington, DC, February 11, 2008, 
(http://pewhispanic.org/files/reports/85.pdf).
    2. CDC, ``Prevalence of Overweight, Obesity, and Extreme Obesity 
Among Adults: United States, Trends 1976-80 Through 2005-2006,'' 
December 2008, (http://www.cdc.gov/nchs/data/hestat/overweight/overweight_adult.pdf).
    3. 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, July 17, 2009, (http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5827a2.htm).
    4. CDC, ``Health Disparities Experienced by Hispanics--United 
States,'' Morbidity and Mortality Weekly Report, 53(40):935-937, 
October 15, 2004, (http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5340a1.htm).
    5. National Heart, Lung and Blood Institute, ``Epidemiologic 
Research in Hispanic Populations: Opportunities, Barriers and 
Solutions,'' December 3, 2003, (http://www.nhlbi.nih.gov/meetings/workshops/hispanic.htm).
    6. Information Resources, Inc., ``Times & Trends: Hispanic 
Consumers--Capturing CPG Market Potential,'' April 2008, (http://www.symphonyiri.com/portals/0/articlePdfs/TT_April_2008_Hispanic_Consumers.pdf).
    7. 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, September 11, 
1998, (http://www.cdc.gov/mmwr/preview/mmwrhtml/00054714.htm).
    8. Lin, C.-T.J. and S.T. Yen, ``Knowledge of Dietary Fats Among 
U.S. Consumers,'' Journal of the American Dietetic Association, 
110(4):613-618, April 2010.
    9. 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.
    10. 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.
    11. 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.
    12. 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.
    13. 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.
    14. 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):1365-1375, 1993.
    15. 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.
    16. Cobas, J.A., H. Balcazar, M.B. Benin, et al., 
``Acculturation and Low-Birthweight Infants Among Latino Women: A 
Reanalysis of Hispanic Health and Nutrition Examination Survey Data 
With Structural Equation Models,'' American Journal of Public 
Health, 86(3):394-396, 1996.
    17. Dixon, L.B., J. Sundquist, and M. Winkleby, ``Differences in 
Energy, Nutrient, and Food Intakes in a U.S. 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):548-557, 2000.
    18. 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.
    19. Markides, K.S., D.J. Lee, and L.A. Ray, ``Acculturation and 
Hypertension in Mexican Americans,'' Ethnicity & Disease, 3:70-74, 
1993.
    20. 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):484-492, 1992.
    21. 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):723-730, 1999.
    22. Thomson, M.D., and L. Hoffman-Goetz, ``Defining and 
Measuring Acculturation: A Systematic Review of Public Health 
Studies With Hispanic Population in the United States,'' Social 
Science & Medicine, 69:983-991, 2009.

    Dated: August 18, 2011.
David Dorsey,
Acting Associate Commissioner for Policy and Planning.
[FR Doc. 2011-21485 Filed 8-22-11; 8:45 am]
BILLING CODE 4160-01-P