[Federal Register Volume 78, Number 106 (Monday, June 3, 2013)]
[Notices]
[Pages 33095-33096]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-13038]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-13-13KZ]


Agency Forms Undergoing Paperwork Reduction Act Review

    The Centers for Disease Control and Prevention (CDC) publishes a 
list of information collection requests under review by the Office of 
Management and Budget (OMB) in compliance with the Paperwork Reduction 
Act (44 U.S.C. Chapter 35). To request a copy of these requests, call 
(404) 639-7570 or send an email to [email protected]. Send written comments 
to CDC Desk Officer, Office of Management and Budget, Washington, DC or 
by fax to (202) 395-5806. Written comments should be received within 30 
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 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. 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 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. CDC plans to conduct a new Salt Sources Study to 
obtain 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.
    Information will be collected 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 collect duplicate portions of their cooking/table salt. 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. CDC will ask about 25 participants at each site to use a Study 
Salt for 11 days instead of their own household salt, 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. The Study Salt contains a very small 
amount of lithium, a metal found in trace amounts in all plants and 
animals.
    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.
    OMB approval is requested for two years. Participation in the Salt 
Sources Study is voluntary and there are no costs to participants other 
than their time. The total estimated annualized burden hours are 1,372.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                Number of        Average burden
       Type of respondents               Form name           Number of        responses per    per response  (in
                                                            respondents         respondent            hr)
----------------------------------------------------------------------------------------------------------------
Adults aged 18-74 years..........  Telephone                           225                  1              10/60
                                    Recruitment and
                                    Screening.
                                   Participant                         225                  1              10/60
                                    Questionnaire.
                                   Discretionary Salt                  225                  1               5/60
                                    Use Questions from
                                    NHANES 2009.
                                   Height and Weight...                225                  1              10/60
                                   Study Orientation                   225                  1              20/60
                                    and Scheduling.
                                   Tap Water                           225                  1               5/60
                                    Questionnaire.
                                   24-Hour Dietary                     225                  4              30/60
                                    Recall.
                                   Food Record.........                225                  4              15/60
                                   Duplicate Salt                      225                  4              10/60
                                    Sample Collection.
                                   Water Collection                     15                  1               5/60
                                    Form and
                                    Instructions.
                                   24-hour Urine                        75                  4              50/60
                                    Collection.
                                   Follow-up Urine                      75                  4              10/60
                                    Collection
                                    Questionnaire.

[[Page 33096]]

 
                                   Study Salt                           75                  3               5/60
                                    Supplement
                                    Questionnaire.
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Ron A. Otten,
Director, Office of Scientific Integrity, Office of the Associate 
Director for Science, Office of the Director, Centers for Disease 
Control and Prevention.
[FR Doc. 2013-13038 Filed 5-31-13; 8:45 am]
BILLING CODE 4163-18-P