Federal Register / Vol. 76, No. 163 / Tuesday, August 23, 2011 / Notices 52665 

appropriate for use in the development 

of RELs? What is the utility of a 

standard ’’action level’’ (i.e., an 

exposure limit set below the REL 

typically used to trigger risk 

management actions) and how should it 

be set? How should NIOSH address 

worker exposure to complex mixtures? 

SUPPLEMENTARY INFORMATION: NIOSH 

and stakeholders have expressed 

concerns recently about limitations in 

the NIOSH Carcinogen Policy, 

prompting NIOSH to initiate a review of 

the carcinogen policy in 2010. A major 

limitation in the policy is the use of the 

term ‘‘Potential Occupational 

Carcinogen’’ which dates to the 1980 

OSHA hazard classification for 

carcinogens outlined in 29 CFR 

1990.103 and is defined as ‘‘* * * any 

substance, or combination or mixture of 

substances, which causes an increased 

incidence of benign and/or malignant 

neoplasms, or a substantial decrease in 

the latency period between exposure 

and onset of neoplasms in humans or in 

one or more experimental mammalian 

species as the result of any oral, 

respiratory or dermal exposure, or any 

other exposure which results in the 

induction of tumors at a site other than 

the site of administration. This 

definition also includes any substance 

which is metabolized into one or more 

potential occupational carcinogens by 

mammals.’’ A major limitation of this 

definition is that the policy allows for 

only one cancer category, which is 

‘‘potential occupational carcinogen.’’ 

The adjective ‘‘potential’’ conveys 

uncertainty that is not warranted with 

many carcinogens such as asbestos, 

benzene, and others. This policy does 

not allow for classification on the basis 

of the magnitude and sufficiency of the 

scientific evidence. In contrast, other 

organizations, such as the International 

Agency for Research on Cancer (IARC) 

and the National Toxicology Program 

(NTP) allow for a more differential 

classification. 

The revision of the NIOSH Carcinogen 

Policy also coincides with the 

international realization that there is a 

need for more efficient and quicker 

means of classifying chemicals. 

Qualitative and semi-quantitative 

approaches such as hazard banding are 

increasingly being investigated as a 

means of addressing the vast numbers of 

unregulated chemicals. NIOSH has been 

in collaboration with various 

organizations to consider utilizing 

hazard banding approaches to control 

chemicals. This will also be reflected in 

the review of the carcinogen and RELs 

policies. 

This Federal Register notice serves to 

provide stakeholders and the public an 

opportunity for input on the revision of 

the NIOSH Carcinogen and REL 

Policies. It is anticipated that NIOSH 

will develop a report on the revised 

NIOSH Carcinogen and REL Policies to 

be made available in the Spring of 2012. 

Additional information regarding 

NIOSH plans to assess and revise the 

Carcinogen and REL Policy can be 

found in the April 2011 NIOSH e-news 

at http://www.cdc.gov/niosh/enews/ 

enewsV8N12.html and on the NIOSH 

Cancer and REL Policy Web Topic Page 

[see http://www.cdc.gov/niosh/topics/ 

cancer/policy.html]. 

FOR FURTHER INFORMATION CONTACT: T.J. 

Lentz, telephone (513) 533–8260, or 

Faye Rice, telephone (513) 533–8335, 

NIOSH, MS–C32, Robert A. Taft 

Laboratories, 4676 Columbia Parkway, 

Cincinnati, Ohio 45226. 

Dated: August 12, 2011. 

John Howard, 

Director, National Institute for Occupational 

Safety and Health, Centers for Disease Control 

and Prevention. 

[FR Doc. 2011–21405 Filed 8–22–11; 8:45 am] 

BILLING CODE 4163–19–P 

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. 

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 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–New and 

title ‘‘Comparing Nutrition Knowledge, 

Attitude, and Behavior Among EnglishDominant 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 EnglishDominant Hispanics, SpanishDominant 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 

mstockstill on DSK4VPTVN1PROD with NOTICES

52666 Federal Register / Vol. 76, No. 163 / Tuesday, August 23, 2011 / Notices 

(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 Englishdominant Hispanics and of nonHispanics 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 Spanishdominant Hispanics, English-dominant 

Hispanics, and English-speaking nonHispanics 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 Webbased 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

Activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

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 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

mstockstill on DSK4VPTVN1PROD with NOTICES

Federal Register / Vol. 76, No. 163 / Tuesday, August 23, 2011 / Notices 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. 

Pe ́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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–D–0386] 

International Conference on 

Harmonisation; Guidance on E2F 

Development Safety Update Report; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a guidance entitled ‘‘E2F 

Development Safety Update Report.’’ 

The guidance was prepared under the 

auspices of the International Conference 

on Harmonisation of Technical 

Requirements for Registration of 

Pharmaceuticals for Human Use (ICH). 

The guidance describes the format, 

content, and timing of a development 

safety update report (DSUR) for an 

investigational drug. The DSUR will 

serve as a common standard for periodic 

reporting on drugs under development 

(including marketed drugs that are 

under further study) among the ICH 

regions. The DSUR can be submitted in 

the United States in place of an annual 

report for an investigational new drug 

application (IND). The harmonized 

DSUR is intended to promote a 

consistent approach to annual clinical 

safety reporting among the ICH regions 

and enhance efficiency by reducing the 

number of reports generated for 

submission to the regulatory authorities. 

DATES: Submit either electronic or 

written comments on Agency guidances 

at any time. 

ADDRESSES: Submit written requests for 

single copies of the guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 2201, 

Silver Spring, MD 20993–0002, or the 

Office of Communication, Outreach and 

Development (HFM–40), Center for 

Biologics Evaluation and Research, 

Food and Drug Administration, 1401 

Rockville Pike, Rockville, MD 20852– 

1448. Send one self-addressed adhesive 

label to assist the office in processing 

your requests. The guidance may also be 

obtained by mail by calling the Center 

for Biologics Evaluation and Research at 

1–800–835–4709 or 301–827–1800. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the guidance 

document. 

Submit electronic comments on the 

guidance to http://www.regulations.gov. 

mstockstill on DSK4VPTVN1PROD with NOTICES