NIH shall
exercise caution in reporting study results and will disclose all
study limitations when such results are publicly disclosed,
particularly concerning the cross-sectional components of this
study (e.g. the inability of this study to rigorously assess
differences by country of origin within the 4 study sites due to
geographical clustering by country of origin, etc.).
Inventory as of this Action
Requested
Previously Approved
03/31/2012
36 Months From Approved
02/28/2011
66,640
0
61,307
48,114
0
44,168
0
0
0
This project seeks to determine the
prevalence of risk factors for cardiovascular disease among
Hispanics living in the U.S. and their realtionship to
cardiovascular morbidity and mortality.
US Code:
42
USC 285b-3 Name of Law: Public Health Service Act
The changes to the estimated
participant burden in this application come from the following
sources: (1) the addition of a claudication questionnaire
(Claudication_2-25-08.doc; Claudication_03-03-08_span.doc) at the
baseline exam to meet the goal of documenting peripheral vascular
disease and an optional exit interview form (Exit
Interview_10-24-08.doc ; Exit Interview_10-24-08_span.doc) designed
to help the study understand how to make the experience better for
the participant, and (2) the addition of a food propensity
questionnaire (FPQ_English_11-04-08.doc ; FPQ_Spanish_11-04-08.doc)
to collect food frequency in order to adjust the nutrient recall
information collected at baseline for the participants usual
dietary intake. The FPQ will be conducted one-year after the
baseline exam in a phone call separate from the Annual Follow-Up
call. The overall burden for the Annual Follow-Up (AFU) has not
changed since the previous submission, however the AFU component
has been modified as follows. Participant burden has been minimized
over the 3 years of projected annual follow-up by developing 3
variations of the AFU form. The version of the form for year 1
(Annual Followup_Y1_11-03-08.doc ) has reduced content. AFU forms
for years 2 and 3 (Annual Followup_Y2_11-03-08.doc ; Annual
Followup_Y3_11-03-08.doc ) each have slightly different content and
may be longer to administer depending upon the general health of
the participant since baseline. The neurocognitive AFU component is
only performed on participants aged 45 and over. The average time
across all three years for a participant with the AFU questionnaire
remains at 30 minutes contact time per year. See Table A.15 below
for a summary of AFU by contact year. The Informant Interview has
been modified to include episodes of angina and shortness of
breath. The Physician Interview form has been modified by expanding
adding sections on asthma, COPD, transient ischemic attack,
congestive heart failure and vascular related surgeries.
On behalf of this Federal agency, I certify that
the collection of information encompassed by this request complies
with 5 CFR 1320.9 and the related provisions of 5 CFR
1320.8(b)(3).
The following is a summary of the topics, regarding
the proposed collection of information, that the certification
covers:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a
benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control
number;
If you are unable to certify compliance with any of
these provisions, identify the item by leaving the box unchecked
and explain the reason in the Supporting Statement.
Form 1 Food Propensity
HCHS -Supporting Statement Dec.01.08.doc
OMB budget repspone brf(1).1-31-08.xls
IRBapproval.Bronx .PDF
OMB Burden_Notice_Nov08 (2).ppt
Food Propensity