[Federal Register Volume 78, Number 42 (Monday, March 4, 2013)]
[Notices]
[Pages 14092-14094]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-04896]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-13-13KZ]
Proposed Data Collections Submitted for Public Comment and
Recommendations
In compliance with the requirement of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995 for opportunity for public comment on
proposed data collection projects, the Centers for Disease Control and
Prevention (CDC) will publish periodic summaries of proposed projects.
To request more information on the proposed projects or to obtain a
copy of the data collection plans and instruments, call 404-639-7570 or
send comments to Ron Otten, at 1600 Clifton Road, MS D74, Atlanta, GA
30333 or send an email to [email protected].
Comments are invited on: (a) Whether the proposed collection of
information is necessary for the proper performance of the functions of
the agency, including whether the information shall have practical
utility; (b) the accuracy of the agency's estimate of the burden of the
[[Page 14093]]
proposed collection of information; (c) ways to enhance the quality,
utility, and clarity of the information to be collected; and (d) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques or other
forms of information technology. Written comments should be received
within 60 days of this notice.
Proposed Project
Salt Sources Study--New--National Center for Chronic Disease
Prevention and Health Promotion (NCCDPHP), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
Stroke and coronary heart disease are the leading causes of
morbidity and mortality in the United States, and account for billions
of dollars in annual health care costs and productivity. Stroke and
heart disease are directly related to high blood pressure, a condition
that affects about 67 million Americans (31 percent of U.S. adults).
Sodium intake directly and progressively increases blood pressure and
subsequently increases the risk of heart disease and stroke. Recent
evidence also indicates excess sodium can damage the heart, vessels,
and kidneys without increasing blood pressure. It has been estimated
that an average reduction of as little as 400 mg of sodium daily, or
about 11% of average U.S. sodium intake, would prevent more than 28,000
deaths and save 7 billion health care dollars annually.
The Institute of Medicine (IOM, 2010) has recommended phased
reductions in the sodium content of packaged foods and menu items, and
voluntary actions by industry to reduce the sodium content of food.
Public comments on these strategies have been solicited by the Food and
Drug Administration (FDA) and the U.S. Department of Agriculture
(USDA). In addition, the U.S. Department of Health and Human Services
(HHS) has designated reduction in sodium intake as one of CDC's
Winnable Battles, as a component of the Million HeartsTM
initiative, and as a Healthy People 2020 objective.
There is a critical need for current, accurate information about
the sources of sodium intake among diverse groups of adults living in
the United States. A study conducted in 1991 (N=62) estimated that 77%
of sodium consumed was from sodium added to packaged and restaurant
foods during commercial processing, about 11% came from salt added at
the table or during cooking, and 12% was naturally occurring (inherent)
in food and beverages. Results from this study have been used to inform
and prioritize efforts to reduce sodium in U.S. packaged and restaurant
foods. For example, the data have been used to inform estimation
equations for discretionary sodium intake (salt added at the table) and
to estimate average total sodium intake. However, the study was not
designed to produce estimates for population subgroups.
Since 1991, the U.S. has undergone demographic shifts in age, race,
and ethnicity, changes in food consumption patterns, and changes in the
geographic distribution of the population. CDC therefore plans to
conduct a new Salt Sources Study to obtain updated information about
the amount of sodium consumed from various sources (including sodium
from processed and restaurant foods, sodium inherent in foods, and salt
added at the table and during cooking) and to examine variability
across population subgroups. Data collection will include an
observational component as well as a sub-study designed to refine the
accuracy of estimates of total sodium intake and discretionary sodium
intake.
The Salt Sources Study will include participants in three distinct
geographic regions: (1) Minneapolis/St. Paul, Minnesota, (2)
Birmingham, Alabama, and (3) Palo Alto, California. Over a two-year
period, a study center in each location will recruit 150 participants
(total N=450) with the aim of selecting an equal number of adults ages
18-74 years by approximately 10-year age groups in each sex-race group,
including whites, blacks, Hispanics, and Asians. A sub-study will be
conducted among a subgroup of 150 of these participants (50 per site).
One study center will serve as a study coordinating center and will
transmit de-identified information to CDC through a secure Web site.
CDC is authorized to conduct this information collection under section
301 of the Public Health Service Act (42 U.S.C. 241).
For the observational study component, CDC estimates that each
study site will enroll 75 participants per year. After completing a
screening process, each participant will complete a personal
questionnaire, a tap water questionnaire, four 24-hour dietary recalls,
and four qualitative food records. In addition, height and weight
information on each participant will be collected, and each participant
will provide samples of their cooking/table salt for independent
analysis. Fifteen participants at each site will also provide water
samples that will be analyzed to produce estimates of the amount of
sodium in private sources of tap water.
The Salt Sources Study will include a sub-study to help determine
the accuracy of estimates of total sodium intake and discretionary salt
intake. We will ask participants to use a Study Salt for 11 days
instead of their own household salt. The Study Salt contains a very
small amount of lithium, a metal found in trace amounts in all plants
and animals. Seventy-five respondents who are participating in the
observational study (approximately 25 respondents from each study site)
will provide additional information based on four 24-hour urine
collections, four follow-up urine collection questionnaires, and three
follow-up questionnaires on Study Salt use.
Results from the Salt Sources Study will be used to inform public
health strategies to reduce sodium intake, determine if substantial
variability in sources of sodium intake exists by socio-demographic
subgroups, and better inform estimates of salt added at the table used
in Healthy People 2020 objectives related to sodium reduction.
Participation in the Salt Sources Study is voluntary. There are no
costs to participants other than their time.
Estimated Annualized Burden Hours
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Average
Number of Number of burden per Total burden
Type of respondents Form name respondents responses per response (in (in hr)
respondent hr)
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Adults aged 18-74 years....... Telephone 225 1 10/60 38
Recruitment and
Screening.
Participant 225 1 10/60 38
Questionnaire.
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Discretionary 225 1 5/60 19
Salt Use
Questions from
NHANES 2009.
Height and 225 1 10/60 38
Weight.
Study 225 1 20/60 75
Orientation and
Scheduling.
Tap Water 225 1 5/60 19
Questionnaire.
24-Hour Dietary 225 4 30/60 450
Recall.
Food Record..... 225 4 15/60 225
Duplicate Salt 225 4 10/60 150
Sample
Collection.
Water Collection 15 1 5/60 1
Form and
Instructions.
24-hour Urine 75 4 50/60 250
Collection.
Follow-up Urine 75 4 10/60 50
Collection
Questionnaire.
Study Salt 75 3 5/60 19
Supplement
Questionnaire.
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Total..................... ................ .............. .............. .............. 1,372
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Dated: February 26, 2013.
Ron A. Otten,
Director, Office of Scientific Integrity (OSI), Office of the Associate
Director for Science (OADS), Office of the Director, Centers for
Disease Control and Prevention.
[FR Doc. 2013-04896 Filed 3-1-13; 8:45 am]
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