Agency Information Collection Activities; Proposed Collection; Comment Request; Comparing Nutrition Knowledge, Attitude, and Behavior Among English-Dominant Hispanics, Spanish-Dominant Hispanics, and Other Consumers, 13626-13629 [2011-5736]
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13626
Federal Register / Vol. 76, No. 49 / Monday, March 14, 2011 / Notices
TABLE 2—ESTIMATED AVERAGE ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
Annual
frequency of
recordkeeping
801.150(a)(2) .....................................................................
801.410(e) and (f) ..............................................................
801.421(d) ..........................................................................
57
30
10,000
1
924,100
160
57
27,723,000
1,600,000
0.50
0.0008
0.25
29
22,178
400,000
Total ............................................................................
........................
........................
........................
..........................
422,207
21 CFR section
1 There
Hours per
record
Total hours
are no capital costs or operating and maintenance costs associated with this collection of information.
The medical device labeling
regulations also refer to previously
approved collections of information
found in FDA regulations. The
collections of information under
§ 800.12(d) and 801.437(i) have been
approved under OMB control number
0910–0183; the collections of
information under § 800.12(e) have been
approved under OMB control number
0910–0231; and the collections of
information under § 801.435(g) have
been approved under OMB control
number 0910–0073.
Further, FDA concludes that labeling
statements under §§ 801.63,
801.405(b)(2) and (b)(3), 801.420(c)(2)
and (c)(3), 801.430(c) and (e)(1),
801.433, 801.437(d) through (g), and
809.30(d)(2), (d)(3), and (e) do not
constitute a ‘‘collection of information’’
under the PRA. Rather, these labeling
statements are ‘‘public disclosure’’ of
information originally supplied by the
Federal Government to the recipient for
the purpose of ‘‘disclosure to the public’’
(5 CFR 1320.3(c)(2)).
Reporting
These estimates are based on FDA’s
registration and listing database for
medical device establishments and
FDA’s knowledge of and experience
with device labeling.
mstockstill on DSKH9S0YB1PROD with NOTICES
Total annual
records
16:20 Mar 11, 2011
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Dated: March 4, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–5739 Filed 3–11–11; 8:45 am]
BILLING CODE 4160–01–P
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.
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
SUMMARY:
Recordkeeping
These estimates are based on FDA’s
registration and listing database for
medical device establishments, Agency
communications with industry, and
FDA’s knowledge of and experience
with device labeling.
The medical device labeling
regulations also refer to previously
approved collections of information.
The collections of information under
§§ 800.12(d) and 801.437(i) have been
approved under OMB control number
0910–0183; and the collections of
information under § 800.12(e) have been
approved under OMB control number
0910–0231.
The information collection
requirements under §§ 801.63,
801.405(b)(2) and (b)(3), 801.420(c)(2)
and (c)(3), 801.430(c) and (e)(1),
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801.433, 801.437(d) through (g), and
809.30(d)(2), (d)(3), (e) are not
considered information collection
because the public information is
originally supplied by the Federal
Government to the recipient for the
purpose of disclosure to the public (5
CFR 1320.3(c)(2)).
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information to https://
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
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Federal Register / Vol. 76, No. 49 / Monday, March 14, 2011 / Notices
of automated collection techniques,
when appropriate, and other forms of
information technology.
Comparing Nutrition Knowledge,
Attitude, and Behavior Among EnglishDominant Hispanics, SpanishDominant Hispanics, and Other
Consumers—(OMB Control Number
0910–NEW)
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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 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 9).
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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 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,
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13627
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 15minute (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 15minute (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:
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Federal Register / Vol. 76, No. 49 / Monday, March 14, 2011 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Portion of study
Annual
frequency per
response
Total annual
responses
Hours per
response
Total hours
Cognitive interview screener ................................................
Cognitive interview ...............................................................
Pretest invitation ..................................................................
Pretest ..................................................................................
Survey invitation ...................................................................
Survey ..................................................................................
72
9
960
180
19,200
2,400
1
1
1
1
1
1
72
9
960
180
19,200
2,400
0.083
0.5
0.033
0.25
0.033
0.25
6
5
32
45
634
600
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 https://
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
https://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 https://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
https://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
https://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
https://pewhispanic.org/files/reports/
121.pdf, April 10, 2010.
7. Information Resources, INC.,
‘‘Times & Trends: Hispanic
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16:20 Mar 11, 2011
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Consumers—Capturing CPG Market
Potential,’’ available at https://
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 FoodHandling, 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 https://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.
´
Perez-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
PO 00000
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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 BreastFeeding 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 LowBirthweight 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. HoffmanGoetz, ‘‘Defining and Measuring
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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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–D–0112]
Draft Guidance for Industry on
Chemistry, Manufacturing, and
Controls Information—FermentationDerived Intermediates, Drug
Substances, and Related Drug
Products for Veterinary Medicinal Use;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry #216 entitled ‘‘Chemistry,
Manufacturing, and Controls (CMC)
Information—Fermentation-Derived
Intermediates, Drug Substances, and
Related Drug Products for Veterinary
Medicinal Use’’. The purpose of this
document is to provide
recommendations on what
documentation to submit to support the
CMC information for fermentationderived intermediates, drug substances,
and related drug products for veterinary
medicinal use.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by May 30, 2011.
ADDRESSES: Submit written requests for
single copies of the guidance to the
Communications Staff (HFV–12), Center
for Veterinary Medicine (CVM), Food
and Drug Administration, 7519 Standish
Pl., Rockville, MD 20855. Send one selfaddressed adhesive label to assist that
office in processing your requests. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the draft
guidance document.
Submit electronic comments on the
draft guidance to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
mstockstill on DSKH9S0YB1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
16:20 Mar 11, 2011
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Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Michael J. Popek, Center for Veterinary
Medicine (HFV–144), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–276–8269, email: michael.popek@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry #216
entitled ‘‘Chemistry, Manufacturing, and
Controls (CMC) Information—
Fermentation-Derived Intermediates,
Drug Substances, and Related Drug
Products for Veterinary Medicinal Use.’’
This draft guidance provides
recommendations on what
documentation to submit to support the
CMC information for fermentationderived intermediates, drug substances,
and related drug products for veterinary
medicinal use. This information is filed
to CVM in a new animal drug
application (NADA), conditional NADA,
investigational new animal drug file,
abbreviated NADA, generic
investigational new animal drug file,
drug master file, or veterinary master
file.
II. Significance of Guidance
This level 1 draft guidance is being
issued consistent with FDA’s good
guidance practices regulation (21 CFR
10.115). The draft guidance, when
finalized, will represent the Agency’s
current thinking on this topic. It does
not create or confer any rights for or on
any person and does not operate to bind
FDA or the public. An alternative
approach may be used if such approach
satisfies the requirements of the
applicable statutes and regulations.
III. Paperwork Reduction Act of 1995
This guidance refers to previously
approved collections of information
found in FDA regulations. These
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3520). The collections of information in
this draft guidance have been approved
under OMB control number 0910–0032
(expiration date April 30, 2011).
IV. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) either electronic or written
comments regarding this document. It is
only necessary to send one set of
comments. It is no longer necessary to
send two copies of mailed comments.
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13629
Identify comments with the docket
number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
V. Electronic Access
Persons with access to the Internet
may obtain the draft guidance at either
https://www.fda.gov/AnimalVeterinary/
GuidanceComplianceEnforcement/
GuidanceforIndustry/default.htm or
https://www.regulations.gov.
Dated: March 8, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–5816 Filed 3–11–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–D–0108]
Revised Draft Guidance for Industry on
User Fee Waivers, Reductions, and
Refunds for Drug and Biological
Products; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a revised draft guidance
for industry entitled ‘‘User Fee Waivers,
Reductions, and Refunds for Drug and
Biological Products.’’ This revised draft
guidance provides recommendations to
applicants considering whether to
request a waiver or reduction in user
fees. This guidance is a revision of the
draft guidance entitled ‘‘Draft Interim
Guidance Document for Waivers of and
Reductions in User Fees,’’ issued July
16, 1993.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
written or electronic comments on the
draft guidance by June 13, 2011.
Submit written comments on the
proposed collection of information by
May 13, 2011.
ADDRESSES: Submit written requests for
single copies of the revised draft
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,
SUMMARY:
E:\FR\FM\14MRN1.SGM
14MRN1
]]>Agencies
[Federal Register Volume 76, Number 49 (Monday, March 14, 2011)]
[Notices]
[Pages 13626-13629]
From the Federal Register Online via the Government Printing 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 https://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 https://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 https://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 https://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 https://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 https://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 https://pewhispanic.org/files/reports/121.pdf, April 10,
2010.
7. Information Resources, INC., ``Times & Trends: Hispanic
Consumers--Capturing CPG Market Potential,'' available at https://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 https://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
