Agency Forms Undergoing Paperwork Reduction Act Review, 33095-33096 [2013-13038]
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33095
Federal Register / Vol. 78, No. 106 / Monday, June 3, 2013 / Notices
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. 2013–13039 Filed 5–31–13; 8:45 am]
BILLING CODE 4163–18–P
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 omb@cdc.gov. 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 substudy 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
Type of respondents
sroberts on DSK5SPTVN1PROD with NOTICES
Adults aged 18–74 years
VerDate Mar<15>2010
Number of
respondents
Form name
Telephone Recruitment and Screening ......................
Participant Questionnaire ...........................................
Discretionary Salt Use Questions from NHANES
2009.
Height and Weight ......................................................
Study Orientation and Scheduling ..............................
Tap Water Questionnaire ...........................................
24-Hour Dietary Recall ...............................................
Food Record ...............................................................
Duplicate Salt Sample Collection ...............................
Water Collection Form and Instructions .....................
24-hour Urine Collection .............................................
Follow-up Urine Collection Questionnaire ..................
19:12 May 31, 2013
Jkt 229001
PO 00000
Frm 00051
Fmt 4703
Sfmt 4703
Number of
responses per
respondent
Average burden
per response
(in hr)
225
225
225
1
1
1
10/60
10/60
5/60
225
225
225
225
225
225
15
75
75
1
1
1
4
4
4
1
4
4
10/60
20/60
5/60
30/60
15/60
10/60
5/60
50/60
10/60
E:\FR\FM\03JNN1.SGM
03JNN1
33096
Federal Register / Vol. 78, No. 106 / Monday, June 3, 2013 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Type of respondents
Study Salt Supplement Questionnaire .......................
75
Ron A. Otten,
Proposed Project
Director, Office of Scientific Integrity, Office
of the Associate Director for Science, Office
of the Director, Centers for Disease Control
and Prevention.
Spectrum of Flavoring ChemicalRelated Lung Disease—New—National
Institute for Occupational Safety and
Health (NIOSH), Centers for Disease
Control and Prevention (CDC).
[FR Doc. 2013–13038 Filed 5–31–13; 8:45 am]
BILLING CODE 4163–18–P
Background and Brief Description
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–13–13BF]
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 omb@cdc.gov. Send written
comments to CDC Desk Officer, Office of
Management and Budget, Washington,
DC 20503 or by fax to (202) 395–5806.
Written comments should be received
within 30 days of this notice.
Number of
responses per
respondent
Number of
respondents
Form name
This project involves a questionnaire,
along with clinical testing, to investigate
and characterize the nature of lung
disease occurring in popcorn and
flavoring workers. Since publication of
the 60-day Federal Register Notice, the
annual burden estimate has been
revised. We added the inclusion of job
and medication forms to be completed
by the participant prior to the testing
session. We also included the time
needed to review the informed consent.
The overall burden hours is now
estimated to be 115 hours.
The purpose of this study is to
investigate the spectrum of lung disease
occurring in flavoring and microwave
popcorn workers. A secondary aim is to
study the natural history of lung
disease. For this study, we plan on
interviewing and conducting clinical
testing on participants from a previously
investigated flavoring plant and
microwave popcorn plant.
For this study, we will recruit
participants from two study
populations: Approximately 112
Average burden
per response
(in hr)
3
5/60
workers from a flavorings plant for
whom we have spirometry data and 132
workers that had abnormal spirometry
on any test from a previous NIOSH
health hazard evaluation at a microwave
popcorn plant. Thirty additional
workers from the microwave popcorn
plant who had normal spirometry on
their last test also will be chosen at
random.
NIOSH anticipates that information
collection will begin in the 2013 fiscal
year for the microwave popcorn workers
and for the flavorings workers in fiscal
year 2014. Prior to the testing,
participants will be mailed a copy of the
informed consent to review and asked to
complete a job history form and current
medication form. This will take no more
than 25 minutes (total) to review and
complete. On the day of testing, a
NIOSH staff member will review the
consent form with the participant,
which will take about 5 minutes.
Participants will then be given a
NIOSH-administered questionnaire
which will take approximately 20
minutes to complete. All study results
will be stored at NIOSH.
Participation in all components of the
study is completely voluntary. There are
no costs to the respondents other than
their time. The total estimated annual
burden hours are 115.
ESTIMATED ANNUALIZED BURDEN HOURS
Form name
Popcorn workers ..............
Informed consent ........................................................
Medication form ..........................................................
Job history form ..........................................................
Questionnaire ..............................................................
Informed consent ........................................................
Medication form ..........................................................
Job history form ..........................................................
Questionnaire ..............................................................
sroberts on DSK5SPTVN1PROD with NOTICES
Flavoring workers .............
VerDate Mar<15>2010
18:49 May 31, 2013
Jkt 229001
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
Average
burden per
response
(in hours)
Number of
responses per
respondent
Number of
respondents
Type of respondents
81
81
81
81
56
56
56
56
E:\FR\FM\03JNN1.SGM
1
1
1
1
1
1
1
1
03JNN1
15/60
5/60
10/60
20/60
15/60
5/60
10/60
20/60
Agencies
[Federal Register Volume 78, Number 106 (Monday, June 3, 2013)]
[Notices]
[Pages 33095-33096]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-13038]
-----------------------------------------------------------------------
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 omb@cdc.gov. 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.
----------------------------------------------------------------------------------------------------------------
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