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 21 Well Being	Form and Instruction	New	Available
Form 19 Tobacco Use	Form and Instruction	New	Available
Form 18 Social Cultural	Form and Instruction	New	Available
Form 17 Sleep	Form and Instruction	New	Available
Form 16 SF 12	Form and Instruction	New	Available
Form 15 Respiratory	Form and Instruction	New	Available
Form 14 Physical Activity	Form and Instruction	New	Available
Form 13 Personal Information	Form and Instruction	New	Available
Form 12 Oral Health	Form and Instruction	New	Available
Form 11 Occupation	Form and Instruction	New	Available
Form 10 Neuro	Form and Instruction	New	Available
Form 9 Medication Use	Form and Instruction	New	Available
Form 8 Medical History	Form and Instruction	New	Available
Form 7 Informed Consent	Form and Instruction	New	Available
Form 6 Hearing Exam	Form and Instruction	New	Available
Form 5 Health Care Use	Form and Instruction	New	Available
Form 4 Economic	Form and Instruction	New	Available
Form 3 Dietary Behavior	Form and Instruction	New	Available
Form 2 Dietary Recall and Supplement Use	Form and Instruction	New	Available
Form 1 Alcohol Use	Form and Instruction	New	Available
Form 20 Weight History	Form and Instruction	New	Available
Form 2 Qx	Form and Instruction	New	Available
Form 1 Letter	Form and Instruction	New	Available
Form 4 Interview	Form and Instruction	New	Available
Form 3 Informant	Form and Instruction	New	Available
Form 2 Annual Follow-up	Form and Instruction	New	Available
Form 1 Recall	Form and Instruction	New	Available
Form 21 Well Being	Form and Instruction	New	Available
Form 20 Weight History	Form and Instruction	New	Available
Form 19 Tobacco Use	Form and Instruction	New	Available
Form 18 Social Cultural	Form and Instruction	New	Available
Form 17 Sleep	Form and Instruction	New	Available
Form 16 SF 12	Form and Instruction	New	Available
Form 15 Respiratory	Form and Instruction	New	Available
Form 14 Physical Activity	Form and Instruction	New	Available
Form 13 Personal Information	Form and Instruction	New	Available
Form 12 Oral Health	Form and Instruction	New	Available
Form 11 Occupation	Form and Instruction	New	Available
Form 10 Neuro	Form and Instruction	New	Repair queued
Form 9 Medication Use	Form and Instruction	New	Available
Form 8 Medical History	Form and Instruction	New	Available
Form 7 Informed Consent	Form and Instruction	New	Available
Form 6 Hearing Exam	Form and Instruction	New	Available
Form 5 Health Care Use	Form and Instruction	New	Available
Form 3 Dietary Behavior	Form and Instruction	New	Available
Form 2 Dietary Recall and Supplement Use	Form and Instruction	New	Available
Form 1 Alcohol Use	Form and Instruction	New	Available
Form 4 Economic	Form and Instruction	New	Available
Form 21 Well Being	Form and Instruction	New	Available
Form 20 Weight History	Form and Instruction	New	Available
Form 19 Tobacco Use	Form and Instruction	New	Available
Form 18 Social Cultural	Form and Instruction	New	Available
Form 17 Sleep	Form and Instruction	New	Available
Form 16 SF 12	Form and Instruction	New	Available
Form 15 Respiratory	Form and Instruction	New	Available
Form 14 Physical Activity	Form and Instruction	New	Available
Form 13 Personal Information	Form and Instruction	New	Available
Form 12 Oral Health	Form and Instruction	New	Available
Form 11 Occupation	Form and Instruction	New	Available
Form 10 Neuro	Form and Instruction	New	Available
Form 9 Medication Use	Form and Instruction	New	Available
Form 8 Medical History	Form and Instruction	New	Available
Form 7 Informed Consent	Form and Instruction	New	Available
Form 6 Hearing Exam	Form and Instruction	New	Available
Form 5 Health Care Use	Form and Instruction	New	Available
Form 4 Economic	Form and Instruction	New	Available
Form 3 Dietary Behavior	Form and Instruction	New	Available
Form 2 Dietary Recall and Supplement Use	Form and Instruction	New	Available
Form 1 Alcohol Use	Form and Instruction	New	Available
Form 2 Screen and Roster	Form and Instruction	New	Available
Form 1 Personal Identifiers	Form and Instruction	New	Available
Form 5 Safety Screen	Form and Instruction	New	Available
Form 4 Phone Script	Form and Instruction	New	Available
Form 3 App. Reminder Call	Form and Instruction	New	Available
Form 2 Residential Response	Form and Instruction	New	Available
Form 1 In Person Script	Form and Instruction	New	Available
Xwalk_rev_12-20-07.doc	Supplementary Document	Uploaded 2008-02-11	Available
Timeline - Hispanic Community Health Study.doc	Supplementary Document	Uploaded 2008-02-11	Available
Protocol.source.doc	Supplementary Document	Uploaded 2008-02-11	Available
Personal Information QxQ_1-29-08.doc	Supplementary Document	Uploaded 2008-02-11	Available
OMB budget repspone brf.1-31-08.xls	Supplementary Document	Uploaded 2008-02-11	Available
Examples of QXQs.doc	Supplementary Document	Uploaded 2008-02-11	Available
Council-Oct.04.pdf	Supplementary Document	Uploaded 2008-02-11	Available
Combined Response.Hispanic Survey - Response to OMB Questions - OMB passback2.doc	Supplementary Document	Uploaded 2008-02-11	Available
CC. HIPAA Form - Revised 1-25-08.doc	Supplementary Document	Uploaded 2008-02-11	Available
Attachments-OMB Passback2.doc	Supplementary Document	Uploaded 2008-02-11	Available
Revised B Supporting Statement 2.8.08.doc	Supporting Statement B	Uploaded 2008-02-11	Available
Well being_span.doc	Supplementary Document	Uploaded 2007-09-13	Available
Weight History_span.doc	Supplementary Document	Uploaded 2007-09-13	Available
Socio cultural_span.doc	Supplementary Document	Uploaded 2007-09-13	Available
Social Network Index_span.doc	Supplementary Document	Uploaded 2007-09-13	Available
Sleep_span.doc	Supplementary Document	Uploaded 2007-09-13	Repair queued
SF12_span.doc	Supplementary Document	Uploaded 2007-09-13	Available
Screen and Roster_span.doc	Supplementary Document	Uploaded 2007-09-13	Available
Respiratory_span.doc	Supplementary Document	Uploaded 2007-09-13	Available
Resident Response_span.doc	Supplementary Document	Uploaded 2007-09-13	Available
Physical Activity_span.doc	Supplementary Document	Uploaded 2007-09-13	Available
Tobacco Use_span.doc	Supplementary Document	Uploaded 2007-09-13	Available
Personal Information_span.doc	Supplementary Document	Uploaded 2007-09-13	Available
Personal Identifiers_span.doc	Supplementary Document	Uploaded 2007-09-13	Available
Oral Health_span.doc	Supplementary Document	Uploaded 2007-09-13	Available
Phone_script_span.doc	Supplementary Document	Uploaded 2007-09-13	Available
Occupation_span.doc	Supplementary Document	Uploaded 2007-09-13	Available
Neurocognitive Assessment_span.doc	Supplementary Document	Uploaded 2007-09-13	Available
Medication Use_span.doc	Supplementary Document	Uploaded 2007-09-13	Available
Medical History_span.doc	Supplementary Document	Uploaded 2007-09-13	Available
Introductory letter_span.doc	Supplementary Document	Uploaded 2007-09-13	Available
Informed Consent_span.doc	Supplementary Document	Uploaded 2007-09-13	Available
Hearing History_span.doc	Supplementary Document	Uploaded 2007-09-13	Available
Hearing Exam_span.doc	Supplementary Document	Uploaded 2007-09-13	Repair queued
Health Care Use_span.doc	Supplementary Document	Uploaded 2007-09-13	Available
Economic_span.doc	Supplementary Document	Uploaded 2007-09-13	Available
Diet and Supplement In-Person Recall_span.doc	Supplementary Document	Uploaded 2007-09-13	Available
Diet and Supplement Phone Script Recall_span.doc	Supplementary Document	Uploaded 2007-09-13	Available
In-person script_span.doc	Supplementary Document	Uploaded 2007-09-13	Available
Appointment Reminder call_09-12-07_span.doc	Supplementary Document	Uploaded 2007-09-13	Available
Alcohol Use_span.doc	Supplementary Document	Uploaded 2007-09-13	Available
Brochure-Span.pdf	Supplementary Document	Uploaded 2007-09-13	Available
San Diego.IRB..doc	Supplementary Document	Uploaded 2008-02-11	Available
UNC_HCHS_Coordinating Center_IRB 2007.pdf	Supplementary Document	Uploaded 2007-09-13	Available
Bronx_IRB. Sep_ 11. 2007 (2).pdf	Supplementary Document	Uploaded 2007-09-13	Available
MIAMI.IRB pending.doc	Supplementary Document	Uploaded 2007-09-13	Available
Northwestern_IRB_approval.pdf	Supplementary Document	Uploaded 2007-09-13	Available
Privacy Policy.doc	Supplementary Document	Uploaded 2007-09-13	Available
Privacy Act.doc	Supplementary Document	Uploaded 2007-09-13	Available
Responses to OMB comments 5-7-07.doc	Supplementary Document	Uploaded 2007-09-13	Available
OSMB Minutes.doc	Supplementary Document	Uploaded 2007-09-13	Available
Epidemiologic Research in Hispanic Populations.doc	Supplementary Document	Uploaded 2007-09-13	Available
Council Minutes.doc	Supplementary Document	Uploaded 2007-09-13	Available
Legislative Mandate.pdf	Supplementary Document	Uploaded 2007-09-13	Available
Revised A Supporting Statement.2.08.08.doc	Supporting Statement A	Uploaded 2008-02-11	Available

IC Document Collections

Information collection document groups

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

ICR Details

OMB Control No: 0925-0584	ICR Reference No: 200709-0925-003
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/NIH	Agency Tracking No:
Title: The Hispanic Community Health Study/ Study of Latinos (HCHS/SOL)(NHLBI)
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 02/11/2008
Retrieve Notice of Action (NOA)	Date Received in OIRA: 09/30/2007
Terms of Clearance: This ICR is approved consistent with revised supporting statements (parts A and B) and with the understanding that funding is available to continue the longitudinal component of this study beyond the three years requested for approval (although it is only the first 3 years of the study that is being approved here). 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	02/28/2011	36 Months From Approved
Responses	61,307	0	0
Time Burden (Hours)	44,168	0	0
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:
	72 FR 37789	07/11/2007
30-day Notice:	Federal Register Citation:	Citation Date:
	72 FR 52153	09/12/2007
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 7

table that charts list of burden

IC Title	Form No.	Form Name
Clinic Exam Procedures	15, 1, 2, 3, 4, 5, 16, 17, 18, 19, 20, 21, 6, 7, 8, 9, 10, 11, 12, 13, 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 ,   Personal Information ,   Physical Activity ,   Respiratory ,   SF 12 ,   Sleep ,   Social Cultural ,   Tobacco Use ,   Weight History ,   Well Being
Clinic Questionaires	1, 2, 3, 4, 5, 6, 14, 15, 16, 17, 18, 19, 20, 21, 7, 8, 9, 10, 11, 12, 13	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
Focus Groups	20, 21, 13, 14, 19, 9, 8, 1, 3, 4, 5, 17, 18, 15, 16, 11, 10, 12, 2, 6, 7	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
Household Enumeration	1, 2	Personal Identifiers ,   Screen and Roster
Non Participant Components	1, 2	Letter ,   Qx
Participant Telephone Interviews	1, 2, 3, 4	Recall ,   Annual Follow-up ,   Informant ,   Interview
Recruitment Contact and Appoinment Confirmation	2, 3, 1, 5, 4	In Person Script ,   Residential Response ,   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	61,307	0	0	61,307	0	0
Annual Time Burden (Hours)	44,168	0	0	44,168	0	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: This is a new information collection.

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Annual Cost to Federal Government: $12,565,175

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: 09/30/2007

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