[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
----------------------------------------------------------------------------------------------------------------
                                                                                      Average
                                                     Number of       Number of      burden per     Total burden
      Type of respondents           Form name       respondents    responses per   response  (in      (in hr)
                                                                    respondent          hr)
----------------------------------------------------------------------------------------------------------------
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.
                                                 ---------------------------------------------------------------
    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]
BILLING CODE 4163-18-P