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