[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
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Number of Average burden
Type of respondents Form name Number of responses per per response (in
respondents respondent hr)
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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