The Hispanic Community Health Study/ Study of Latinos (HCHS/SOL)(NHLBI)

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form 1 survey	Form and Instruction	New	Available
Form 21 Well Being	Form and Instruction	Modified	Available
Form 20 Weight History	Form and Instruction	Modified	Available
Form 19 Tobacco Use	Form and Instruction	Modified	Available
Form 18 Social Cultural	Form and Instruction	Modified	Available
Form 17 Sleep	Form and Instruction	Modified	Available
Form 16 SF12	Form and Instruction	Modified	Available
Form 15 Respiratory	Form and Instruction	Modified	Available
Form 14 Physical Activity	Form and Instruction	Modified	Available
Form 13 Personal Information	Form and Instruction	Modified	Available
Form 12 Oral Health	Form and Instruction	Modified	Available
Form 11 Occupation	Form and Instruction	Modified	Available
Form 2 survey	Form and Instruction	Modified	Available
Form 1 Letter	Form and Instruction	Modified	Available
Form 7 survey	Form and Instruction	Modified	Available
Form 4 survey	Form and Instruction	Modified	Available
Form 6 survey	Form and Instruction	Modified	Available
Form 5 survey	Form and Instruction	Modified	Available
Form 2 survey	Form and Instruction	Modified	Available
Form 3 Informant	Form and Instruction	Modified	Available
Form 1 Recall	Form and Instruction	Modified	Available
Form 23 survey	Form and Instruction	Modified	Available
Form 22 survey	Form and Instruction	Modified	Available
Form 21 Well Being	Form and Instruction	Modified	Available
Form 20 Weight History	Form and Instruction	Modified	Available
Form 19 Tobacco Use	Form and Instruction	Modified	Available
Form 18 Social Cultural	Form and Instruction	Modified	Available
Form 17 Sleep	Form and Instruction	Modified	Available
Form 16 SF 12	Form and Instruction	Modified	Available
Form 15 Respiratory	Form and Instruction	Modified	Available
Form 14 Physical Activity	Form and Instruction	Modified	Available
Form 12 Oral Health	Form and Instruction	Modified	Available
Form 11 Occupation	Form and Instruction	Modified	Available
Form 10 Neuro	Form and Instruction	Modified	Available
Form 8 Medical History	Form and Instruction	Modified	Available
Form 7 Informed Consent	Form and Instruction	Modified	Available
Form 6 Hearing Exam	Form and Instruction	Modified	Available
Form 5 Health Care Use	Form and Instruction	Modified	Available
Form 4 Economic	Form and Instruction	Modified	Available
Form 3 Dietary Behavior	Form and Instruction	Modified	Available
Form 2 Dietary Recall and Supplement Use	Form and Instruction	Modified	Available
Form 1 Alcohol Use	Form and Instruction	Modified	Available
Form 9 Medication Use	Form and Instruction	Modified	Available
Form 21 Well Being	Form and Instruction	Modified	Available
Form 20 Weight History	Form and Instruction	Modified	Available
Form 19 Tobacco Use	Form and Instruction	Modified	Available
Form 18 Social Cultural	Form and Instruction	Modified	Available
Form 17 Sleep	Form and Instruction	Modified	Available
Form 16 SF 12	Form and Instruction	Modified	Available
Form 15 Respiratory	Form and Instruction	Modified	Available
Form 14 Physical Activity	Form and Instruction	Modified	Available
Form 13 Personal Information	Form and Instruction	Modified	Available
Form 11 Occupation	Form and Instruction	Modified	Available
Form 10 Neuro	Form and Instruction	Modified	Available
Form 9 Medication Use	Form and Instruction	Modified	Available
Form 8 Medical History	Form and Instruction	Modified	Available
Form 7 Informed Consent	Form and Instruction	Modified	Available
Form 6 Hearing Exam	Form and Instruction	Modified	Available
Form 5 Health Care Use	Form and Instruction	Modified	Available
Form 4 Economic	Form and Instruction	Modified	Available
Form 3 Dietary Behavior	Form and Instruction	Modified	Available
Form 2 Dietary Recall and Supplement Use	Form and Instruction	Modified	Available
Form 1 Alcohol Use	Form and Instruction	Modified	Available
Form 12 Oral Health	Form and Instruction	Modified	Available
Form 2 Screen and Roster	Form and Instruction	Modified	Available
Form 1 Personal Identifiers	Form and Instruction	Modified	Available
Form 5 Safety Screen	Form and Instruction	Modified	Available
Form 4 Phone Script	Form and Instruction	Modified	Available
Form 3 App. Reminder Call	Form and Instruction	Modified	Available
Form 1 In Person Script	Form and Instruction	Modified	Available
Form 2 Residential Response	Form and Instruction	Modified	Available
HCHS -Supporting Statement Dec.01.08.doc	Supporting Statement B	Uploaded 2008-12-03	Available
Summary of Changes 12 03 08.doc	Supplementary Document	Uploaded 2008-12-03	Available
OMB budget repspone brf(1).1-31-08.xls	Supplementary Document	Uploaded 2008-12-03	Available
Protocol[1].source.doc	Supplementary Document	Uploaded 2008-12-03	Available
Personal Information QxQ_1-29-08[1].doc	Supplementary Document	Uploaded 2008-12-03	Available
Personal Information_11-21-08_span.doc	Supplementary Document	Uploaded 2008-12-03	Available
Examples of QXQs[1].doc	Supplementary Document	Uploaded 2008-12-03	Available
CC[1]. HIPAA Form - Revised 1-25-08.doc	Supplementary Document	Uploaded 2008-12-03	Available
FPQ Spanish_11-04-08.doc	Supplementary Document	Uploaded 2008-12-03	Available
Exit Interview_10-24-08_span.doc	Supplementary Document	Uploaded 2008-12-03	Available
Claudication_3-05-08_span.doc	Supplementary Document	Uploaded 2008-12-03	Available
Informant interview_10-20-08_span_annotated (2).doc	Supplementary Document	Uploaded 2008-12-03	Available
Annual Followup_Y3_11-03-08_span_annotated.doc	Supplementary Document	Uploaded 2008-12-03	Available
Annual Followup_Y2_11-03-08_span_annotated.doc	Supplementary Document	Uploaded 2008-12-03	Available
Annual Followup_Y1_11-03-08_span_annotated.doc	Supplementary Document	Uploaded 2008-12-03	Available
IRBapproval.Bronx .PDF	Supplementary Document	Uploaded 2008-12-03	Available
San Diego.IRB.doc	Supplementary Document	Uploaded 2008-12-03	Available
Northwestern.IRB approval.pdf	Supplementary Document	Uploaded 2008-12-03	Available
HCHS Miami IRB approval.2.pdf	Supplementary Document	Uploaded 2008-12-03	Available
CSCC_letter signed IRB2007-08.pdf	Supplementary Document	Uploaded 2008-12-03	Available
OMB Burden_Notice_Nov08 (2).ppt	Supplementary Document	Uploaded 2008-12-03	Available
Xwalk_rev_11-12-08.doc	Supplementary Document	Uploaded 2008-12-03	Available
OSMB June 08 Minutes.doc	Supplementary Document	Uploaded 2008-12-03	Source copy available
Timeline - Hispanic Community Health Study.doc	Supplementary Document	Uploaded 2008-12-03	Available
Well being_span.doc	Supplementary Document	Uploaded 2008-11-21	Available
Weight History_span.doc	Supplementary Document	Uploaded 2008-11-21	Available
Socio cultural_span.doc	Supplementary Document	Uploaded 2008-11-21	Available
Social Network Index_span.doc	Supplementary Document	Uploaded 2008-11-21	Available
Sleep_span.doc	Supplementary Document	Uploaded 2008-11-21	Available
SF12_span.doc	Supplementary Document	Uploaded 2008-11-21	Available
Screen and Roster_span.doc	Supplementary Document	Uploaded 2008-11-21	Available
Respiratory_span.doc	Supplementary Document	Uploaded 2008-11-21	Available
Resident Response_span.doc	Supplementary Document	Uploaded 2008-11-21	Available
Physical Activity_span.doc	Supplementary Document	Uploaded 2008-11-21	Available
Tobacco Use_span.doc	Supplementary Document	Uploaded 2008-11-21	Available
Personal Information_span.doc	Supplementary Document	Uploaded 2008-11-21	Available
Personal Identifiers_span.doc	Supplementary Document	Uploaded 2008-11-21	Available
Oral Health_span.doc	Supplementary Document	Uploaded 2008-11-21	Available
Phone_script_span.doc	Supplementary Document	Uploaded 2008-11-21	Available
Occupation_span.doc	Supplementary Document	Uploaded 2008-11-21	Available
Neurocognitive Assessment_span.doc	Supplementary Document	Uploaded 2008-11-21	Available
Medication Use_span.doc	Supplementary Document	Uploaded 2008-11-21	Available
Medical History_span.doc	Supplementary Document	Uploaded 2008-11-21	Available
Introductory letter_span.doc	Supplementary Document	Uploaded 2008-11-21	Available
Informed Consent_span.doc	Supplementary Document	Uploaded 2008-11-21	Available
Informed Consent_span.doc	Supplementary Document	Uploaded 2008-11-21	Available
Hearing Exam_span.doc	Supplementary Document	Uploaded 2008-11-21	Available
Health Care Use_span.doc	Supplementary Document	Uploaded 2008-11-21	Available
Diet and Supplement Phone Script Recall_span.doc	Supplementary Document	Uploaded 2008-11-21	Available
Diet and Supplement In-Person Recall_span.doc	Supplementary Document	Uploaded 2008-11-21	Available
In-person script_span.doc	Supplementary Document	Uploaded 2008-11-21	Available
Appointment Reminder call_09-12-07_span.doc	Supplementary Document	Uploaded 2008-11-21	Available
Alcohol Use_span.doc	Supplementary Document	Uploaded 2008-11-21	Available
Epidemiologic Research in Hispanic Populations.doc	Supplementary Document	Uploaded 2008-11-21	Available
Brochure-Span.pdf	Supplementary Document	Uploaded 2008-11-21	Available
Privacy Policy.doc	Supplementary Document	Uploaded 2008-11-21	Available
Privacy Act.doc	Supplementary Document	Uploaded 2008-11-21	Available
Legislative Mandate.pdf	Supplementary Document	Uploaded 2008-11-21	Available
Economic_span.doc	Supplementary Document	Uploaded 2008-11-21	Available
Council Minutes.doc	Supplementary Document	Uploaded 2008-11-21	Available
introductory letter.doc	Supplementary Document	Uploaded 2007-09-13	Available
Brochure-Eng.pdf	Supplementary Document	Uploaded 2007-09-13	Available
Revised A Supporting Statement Dec 01 08.doc	Supporting Statement A	Uploaded 2008-12-03	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
187780	Food Propensity	Form and Instruction	New	survey
183722	Focus Groups	Form and Instruction	Modified	Well Being
183722	Focus Groups	Form and Instruction	Modified	Weight History
183722	Focus Groups	Form and Instruction	Modified	Tobacco Use
183722	Focus Groups	Form and Instruction	Modified	Social Cultural
183722	Focus Groups	Form and Instruction	Modified	Sleep
183722	Focus Groups	Form and Instruction	Modified	SF12
183722	Focus Groups	Form and Instruction	Modified	Respiratory
183722	Focus Groups	Form and Instruction	Modified	Physical Activity
183722	Focus Groups	Form and Instruction	Modified	Personal Information
183722	Focus Groups	Form and Instruction	Modified	Oral Health
183722	Focus Groups	Form and Instruction	Modified	Occupation
182193	Non Participant Components	Form and Instruction	Modified	survey
182193	Non Participant Components	Form and Instruction	Modified	Letter
182192	Participant Telephone Interviews	Form and Instruction	Modified	survey
182192	Participant Telephone Interviews	Form and Instruction	Modified	survey
182192	Participant Telephone Interviews	Form and Instruction	Modified	survey
182192	Participant Telephone Interviews	Form and Instruction	Modified	survey
182192	Participant Telephone Interviews	Form and Instruction	Modified	survey
182192	Participant Telephone Interviews	Form and Instruction	Modified	Informant
182192	Participant Telephone Interviews	Form and Instruction	Modified	Recall
182191	Clinic Questionaires	Form and Instruction	Modified	survey
182191	Clinic Questionaires	Form and Instruction	Modified	survey
182191	Clinic Questionaires	Form and Instruction	Modified	Well Being
182191	Clinic Questionaires	Form and Instruction	Modified	Weight History
182191	Clinic Questionaires	Form and Instruction	Modified	Tobacco Use
182191	Clinic Questionaires	Form and Instruction	Modified	Social Cultural
182191	Clinic Questionaires	Form and Instruction	Modified	Sleep
182191	Clinic Questionaires	Form and Instruction	Modified	SF 12
182191	Clinic Questionaires	Form and Instruction	Modified	Respiratory
182191	Clinic Questionaires	Form and Instruction	Modified	Physical Activity
182191	Clinic Questionaires	Form and Instruction	Modified	Oral Health
182191	Clinic Questionaires	Form and Instruction	Modified	Occupation
182191	Clinic Questionaires	Form and Instruction	Modified	Neuro
182191	Clinic Questionaires	Form and Instruction	Modified	Medical History
182191	Clinic Questionaires	Form and Instruction	Modified	Informed Consent
182191	Clinic Questionaires	Form and Instruction	Modified	Hearing Exam
182191	Clinic Questionaires	Form and Instruction	Modified	Health Care Use
182191	Clinic Questionaires	Form and Instruction	Modified	Economic
182191	Clinic Questionaires	Form and Instruction	Modified	Dietary Behavior
182191	Clinic Questionaires	Form and Instruction	Modified	Dietary Recall and Supplement Use
182191	Clinic Questionaires	Form and Instruction	Modified	Alcohol Use
182191	Clinic Questionaires	Form and Instruction	Modified	Medication Use
182190	Clinic Exam Procedures	Form and Instruction	Modified	Well Being
182190	Clinic Exam Procedures	Form and Instruction	Modified	Weight History
182190	Clinic Exam Procedures	Form and Instruction	Modified	Tobacco Use
182190	Clinic Exam Procedures	Form and Instruction	Modified	Social Cultural
182190	Clinic Exam Procedures	Form and Instruction	Modified	Sleep
182190	Clinic Exam Procedures	Form and Instruction	Modified	SF 12
182190	Clinic Exam Procedures	Form and Instruction	Modified	Respiratory
182190	Clinic Exam Procedures	Form and Instruction	Modified	Physical Activity
182190	Clinic Exam Procedures	Form and Instruction	Modified	Personal Information
182190	Clinic Exam Procedures	Form and Instruction	Modified	Occupation
182190	Clinic Exam Procedures	Form and Instruction	Modified	Neuro
182190	Clinic Exam Procedures	Form and Instruction	Modified	Medication Use
182190	Clinic Exam Procedures	Form and Instruction	Modified	Medical History
182190	Clinic Exam Procedures	Form and Instruction	Modified	Informed Consent
182190	Clinic Exam Procedures	Form and Instruction	Modified	Hearing Exam
182190	Clinic Exam Procedures	Form and Instruction	Modified	Health Care Use
182190	Clinic Exam Procedures	Form and Instruction	Modified	Economic
182190	Clinic Exam Procedures	Form and Instruction	Modified	Dietary Behavior
182190	Clinic Exam Procedures	Form and Instruction	Modified	Dietary Recall and Supplement Use
182190	Clinic Exam Procedures	Form and Instruction	Modified	Alcohol Use
182190	Clinic Exam Procedures	Form and Instruction	Modified	Oral Health
182189	Household Enumeration	Form and Instruction	Modified	Screen and Roster
182189	Household Enumeration	Form and Instruction	Modified	Personal Identifiers
182188	Recruitment Contact and Appoinment Confirmation	Form and Instruction	Modified	Safety Screen
182188	Recruitment Contact and Appoinment Confirmation	Form and Instruction	Modified	Phone Script
182188	Recruitment Contact and Appoinment Confirmation	Form and Instruction	Modified	App. Reminder Call
182188	Recruitment Contact and Appoinment Confirmation	Form and Instruction	Modified	In Person Script
182188	Recruitment Contact and Appoinment Confirmation	Form and Instruction	Modified	Residential Response

ICR Details

OMB Control No: 0925-0584	ICR Reference No: 200901-0925-003
Status: Historical Active	Previous ICR Reference No: 200709-0925-003
Agency/Subagency: HHS/NIH	Agency Tracking No:
Title: The Hispanic Community Health Study/ Study of Latinos (HCHS/SOL)(NHLBI)
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 03/16/2009
Retrieve Notice of Action (NOA)	Date Received in OIRA: 01/12/2009
Terms of Clearance: 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.).

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2012	36 Months From Approved	02/28/2011
Responses	66,640	0	61,307
Time Burden (Hours)	48,114	0	44,168
Cost Burden (Dollars)	0	0	0

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Abstract: 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.

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Authorizing Statute(s): US Code: 42 USC 285b-3 Name of Law: Public Health Service Act
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	73 FR 57634	10/03/2008
30-day Notice:	Federal Register Citation:	Citation Date:
	73 FR 75725	12/12/2008
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 8

table that charts list of burden

IC Title	Form No.	Form Name
Clinic Exam Procedures	1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21	Alcohol Use ,   Dietary Recall and Supplement Use ,   Dietary Behavior ,   Economic ,   Health Care Use ,   Hearing Exam ,   Informed Consent ,   Medical History ,   Medication Use ,   Neuro ,   Occupation ,   Oral Health ,   Personal Information ,   Physical Activity ,   Respiratory ,   SF 12 ,   Sleep ,   Social Cultural ,   Tobacco Use ,   Weight History ,   Well Being
Clinic Questionaires	15, 16, 17, 18, 19, 20, 21, 22, 23, 8, 9, 1, 2, 3, 4, 5, 6, 7, 10, 11, 12, 14	Alcohol Use ,   Dietary Recall and Supplement Use ,   Dietary Behavior ,   Economic ,   Health Care Use ,   Hearing Exam ,   Informed Consent ,   Medical History ,   Medication Use ,   Neuro ,   Occupation ,   Oral Health ,   Physical Activity ,   Respiratory ,   SF 12 ,   Sleep ,   Social Cultural ,   Tobacco Use ,   Weight History ,   Well Being ,   survey ,   survey
Focus Groups	11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21	Occupation ,   Oral Health ,   Personal Information ,   Physical Activity ,   Respiratory ,   SF12 ,   Sleep ,   Social Cultural ,   Tobacco Use ,   Weight History ,   Well Being
Food Propensity	1	survey
Household Enumeration	1, 2	Personal Identifiers ,   Screen and Roster
Non Participant Components	1, 2	Letter ,   survey
Participant Telephone Interviews	1, 3, 2, 5, 6, 4, 7	Recall ,   Informant ,   survey ,   survey ,   survey ,   survey ,   survey
Recruitment Contact and Appoinment Confirmation	2, 1, 3, 4, 5	Residential Response ,   In Person Script ,   App. Reminder Call ,   Phone Script ,   Safety Screen

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ICR Summary of Burden

table that charts list of burden

	Total Approved	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	66,640	61,307	0	5,333	0	0
Annual Time Burden (Hours)	48,114	44,168	0	3,573	373	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: 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.

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Annual Cost to Federal Government: $10,561,179

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? Uncollected

Is this ICR related to the Pandemic Response? Uncollected

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Common Form ICR:  No

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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:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(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;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

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.

Certification Date: 12/17/2008

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