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

Forms and Documents

Document Name	Status
Form 1 PQE Hospitalization records/physician interview Form and Instruction	New
Form 1 IIE-Informant Interview Deaths - Eng Form and Instruction	New
Form 1 AFU Year 11 Form and Instruction	New
Form 1 AFU Year 10 Form and Instruction	New
Form 1 AFU Year 9 Form and Instruction	New
Form 1 AFU Year 8 Form and Instruction	New
Form 1 AFU Year 7 Form and Instruction	New
Form 1 AFU Year 6 Form and Instruction	New
Form 1 AFU Year 5 Form and Instruction	New
Form 1 AFU Year 4 Form and Instruction	New
Form 1 AFU Year 3 Form and Instruction	New
Form 1 Participant Feedback Form and Instruction	New
Form 1 Alcohol Use Form and Instruction	New
Form 1 Tobacco Use Form and Instruction	New
Form 1 Abbreviated Medication Use Form and Instruction	New
Form 1 Well Being Form and Instruction	New
Form 1 Acculturation Form and Instruction	New
Form 1 Social Support Form and Instruction	New
Form 1 Family Cohesion Form and Instruction	New
Form 1 Chronic Stress Form and Instruction	New
Form 1 Health Care Access and Utilization Form and Instruction	New
Form 1 Socio-economic Status - Occupation Form and Instruction	New
Form 1 Pregnancy Complications History Form and Instruction	New
Form 1 Reproductive Medical History Form and Instruction	New
Form 1 Personal Medical History Form and Instruction	New
Form 1 2-hour blood draw, snack Form and Instruction	New
Form 1 Echocardiography Form and Instruction	New
Form 1 Seated BP Form and Instruction	New
Form 1 Determination of blood glucose, OGTT Form and Instruction	New
Form 1 Determination of fasting & blood draw Form and Instruction	New
Form 1 Anthropometry Form and Instruction	New
Form 1 Updated personal information Form and Instruction	New
Form 1 Change clothes, urine specimen Form and Instruction	New
Form 1 Participant safety screeing update and routing Form and Instruction	New
Form 1 Participant disability screening Form and Instruction	New
Form 1 Reception, informed consent, medical releases Form and Instruction	New
Form 3 Participants Follow-up Year 3 to 6 Form and Instruction	Removed
Form 1 Non Participant Components Form and Instruction	Removed
Form 2 Participants Follow-up Year 2 Form and Instruction	Removed
Form 1 Pre-visit scheduling and safety screening Form and Instruction	Modified
Appendix 20 Sources of Questionnaires and Protocols FINAL.doc Supplementary Document	2014-06-27
Appendix 19 - Example of QXQ.pdf Supplementary Document	2014-06-27
HCHS SOL Supporting Statement A 08262014.docx Supporting Statement A	2014-08-28
San Diego Talavera_1586091_SOL Visit 2_New Approval_Minimal Risk_Dec 10 2013mtg.pdf Supplementary Document	2014-06-25
Miami Schneiderman HCHS Visit 2 IRB approval letter_01082014.pdf Supplementary Document	2014-06-25
Chicago Daviglus HCHS Visit 2 UIC IRB Approval 20131261-79111-1.pdf Supplementary Document	2014-06-25
Bronx Kaplan HCHS Visit 2 IRB Approval.pdf Supplementary Document	2014-06-25
SALUD SOLNEWSLETTER_Vol6No2_Bronx_ENG SPA FINAL_TVC_Bronx.pdf Supplementary Document	2014-06-25
Participant Booklet National Alliance 2014.pdf Supplementary Document	2014-06-25
Final pdf NHLBI-HCHSSOL-Spanish-508Rev2-FY14.pdf Supplementary Document	2014-06-25
Final pdf NHLBI-HCHSSOL-English-508Rev2-FY14.pdf Supplementary Document	2014-06-25
JAMA Factsheet FINAL SD Eng Span BackFront.pdf Supplementary Document	2014-06-25
UNC HCHS Coord Center IRB Approval Notice 2013-2014.pdf Supplementary Document	2014-06-25
Appendix 13 UNC CC Privacy Policy.pdf Supplementary Document	2014-06-12
Appendix 12 - Privacy Act System Notice.pdf Supplementary Document	2014-06-12
SOL IC Spanish FINAL 27 Dec 2013.pdf Supplementary Document	2014-06-12
SOL IC English FINAL 27 Dec 2013.pdf Supplementary Document	2014-06-12
San Diego HIPPA Form SOL Visit 2 English 1-17-2014.pdf Supplementary Document	2014-06-12
San Diego HIPAA Form SOL Visit 2 Spanish-1-17-14.pdf Supplementary Document	2014-06-12
Miami HCHS Visit 2 HIPAA FormB-Spanish.pdf Supplementary Document	2014-06-12
Miami HCHS Visit 2 HIPAA FormB-English.pdf Supplementary Document	2014-06-12
Chicago HCHS-SOL-Visit 2 HIPAA English20140103.pdf Supplementary Document	2014-06-12
Chicago HCHS-SOL Visit 2 HIPPA Spanish.pdf Supplementary Document	2014-06-12
Bronx HCHS Updated Spanish HIPAA.pdf Supplementary Document	2014-06-12
Bronx HCHS Updated English HIPAA .pdf Supplementary Document	2014-06-12
Kost Clinical Research Experience.pdf Supplementary Document	2014-06-11
Grady payment.pdf Supplementary Document	2014-06-11
Grady incentives.pdf Supplementary Document	2014-06-11
Appendix 8 - HCHS OSMB Minutes 8 Nov 2013.docx Supplementary Document	2014-06-11
Appendix 7 - NHLBI Advisory Council June 2011 Roster.docx Supplementary Document	2014-06-11
Appendix 6 - NHLBI Council Minutes June 2011.docx Supplementary Document	2014-06-11
Appendix 5 - Future Research Opportunities HCHS SOL 2010.docx Supplementary Document	2014-06-11
Appendix 4 - Epidemiologic Research in Hispanic Populations 2003.docx Supplementary Document	2014-06-11
Appendix 3 - Comparison Visit 1 and Visit 2 HCHS SOL.docx Supplementary Document	2014-06-11
Appendix 2 - NHLBI Legislative Mandate.pdf Supplementary Document	2014-06-11
Appendix 1c Sorlie et al Design and Implementation SOL.pdf Supplementary Document	2014-06-11
Appendix 1b LaVange et al Sampling Design SOL.pdf Supplementary Document	2014-06-11
Appendix 1a Daviglus et al Prevalence of CVD risk Factors.pdf Supplementary Document	2014-06-11
HCHS SOL Supporting Statement B FINAL May2014.docx Supporting Statement B	2014-06-09

IC Document Collections

IC ID	Document Title	Status
212138	PQE Hospitalization records/physician interview Form and Instruction	New
212135	IIE-Informant Interview Deaths - Eng Form and Instruction	New
211993	AFU Year 11 Form and Instruction	New
211992	AFU Year 10 Form and Instruction	New
211991	AFU Year 9 Form and Instruction	New
211990	AFU Year 8 Form and Instruction	New
211989	AFU Year 7 Form and Instruction	New
211988	AFU Year 6 Form and Instruction	New
211987	AFU Year 5 Form and Instruction	New
211986	AFU Year 4 Form and Instruction	New
211985	AFU Year 3 Form and Instruction	New
211984	Participant Feedback Form and Instruction	New
211983	Alcohol Use Form and Instruction	New
211981	Tobacco Use Form and Instruction	New
211980	Abbreviated Medication Use Form and Instruction	New
211979	Well Being Form and Instruction	New
211978	Acculturation Form and Instruction	New
211977	Social Support Form and Instruction	New
211976	Family Cohesion Form and Instruction	New
211975	Chronic Stress Form and Instruction	New
211974	Health Care Access and Utilization Form and Instruction	New
211973	Socio-economic Status - Occupation Form and Instruction	New
211972	Pregnancy Complications History Form and Instruction	New
211971	Reproductive Medical History Form and Instruction	New
211970	Personal Medical History Form and Instruction	New
211969	2-hour blood draw, snack Form and Instruction	New
211968	Echocardiography Form and Instruction	New
211967	Seated BP Form and Instruction	New
211966	Determination of blood glucose, OGTT Form and Instruction	New
211965	Determination of fasting & blood draw Form and Instruction	New
211964	Anthropometry Form and Instruction	New
211962	Updated personal information Form and Instruction	New
211961	Change clothes, urine specimen Form and Instruction	New
211960	Participant safety screeing update and routing Form and Instruction	New
211959	Participant disability screening Form and Instruction	New
211917	Reception, informed consent, medical releases Form and Instruction	New
199868	Participants Follow-up Year 3 to 6 Form and Instruction	Removed
182193	Non Participant Components Form and Instruction	Removed
182189	Participants Follow-up Year 2 Form and Instruction	Removed
182188	Pre-visit scheduling and safety screening Form and Instruction	Modified

ICR Details

OMB Control No: 0925-0584	ICR Reference No: 201406-0925-002
Status: Historical Active	Previous ICR Reference No: 201110-0925-002
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 with change	Conclusion Date: 08/29/2014
	Date Received in OIRA: 07/17/2014
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2017	36 Months From Approved	12/31/2014
Responses	470,709	0	17,284
Time Burden (Hours)	74,386	0	5,309
Cost Burden (Dollars)	0	0	0

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Abstract: The overall purpose of the continuation of the HCHS/SOL is to estimate the incidence of cardiovascular risk factors and risk factors for other chronic diseases, and their relationship to baseline cardiometabolic and general health profile and to the incidence of cardiovascular events (morbidity), cardiovascular mortality and all-cause mortality in a randomly selected sample of men and women who self-identified as Hispanic, and who represent four different communities in the U.S. The Field Centers are located in San Diego (San Diego State University), Chicago (University of Illinois at Chicago), New York (Albert Einstein Medical College-Montefiore Medical Center), and Miami (University of Miami). Coordination of methods, instruments, training, and data analysis will take place at the University of North Carolina at Chapel Hill. In addition, an Echocardiography Reading Center at Brigham and Women's Hospital will oversee the collection of echocardiographic data and its interpretation and analysis.

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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:
	79 FR 16345	03/25/2014
30-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 41293	07/15/2014
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 37

IC Title	Form No.	Form Name
IIE-Informant Interview Deaths - Eng	1	IIE Informant Interview Deaths
PQE Hospitalization records/physician interview	1	PQE-Physician Interview
Anthropometry	1	ANT-Anthropometry
Determination of fasting & blood draw	1	BIO-Biospecimen Collection
Determination of blood glucose, OGTT	1	BIO-Biospecimen Collection
Seated BP	1	SBP-Sitting Blood Pressure
Echocardiography	1	Echocardiography Manual
Health Care Access and Utilization	1	HCE-HealthCare-Eng
Chronic Stress	1	STE-Chronic Stress-Eng
Social Support	1	Social Support
Acculturation	1	Acculturation Questionnaire
AFU Year 3	1	AFU Year 3
AFU Year 4	1	AFU Year 4 English
AFU Year 10	1	AFU-Years 7-11 Annual Followup English
Reception, informed consent, medical releases	1	SOL IC English
Participants Follow-up Year 2	2, 1	Interview ,   Food Propensity
Non Participant Components	1, 2	Questionaire ,   Informant Interview
Participants Follow-up Year 3 to 6	3, 4, 5, 6	Interview ,   Interview ,   Interview ,   Interview
Pre-visit scheduling and safety screening	1	ELE-Participant eligibility - billingual
Tobacco Use	1	Tobacco
Personal Medical History	1	MHE-Personal Medical History-Eng
Well Being	1	Well Being
Abbreviated Medication Use	1	MSE-Medication Use Survey -Eng
Alcohol Use	1	Alcohol Use
Participant Feedback	1	Participant Feedback
AFU Year 5	1	AFU-Year 5 Annual Followup English
AFU Year 6	1	AFU year 6 Annual followup English
AFU Year 7	1	AFU-Years7-11 Annual Followup English
AFU Year 8	1	AFU-Years 7-11 Annual followup English
AFU Year 9	1	AFU- Years 7-11 Annual Followup English
AFU Year 11	1	AFU-Years7-11 Annual Followup English
Change clothes, urine specimen	1	BIO-Biospecimen Collection
Updated personal information	1	IDE-Personal Identifiers-Eng
2-hour blood draw, snack	1	BIO-Biospecimen Collection
Participant disability screening	1	PDE-Participant Disability Screen Eng
Participant safety screeing update and routing	1	PSE-Participant Safety Screen
Reproductive Medical History	1	RME-Repro and Medical History-Eng
Pregnancy Complications History	1	PCE-Pregnancy Complications Hx - Eng
Socio-economic Status - Occupation	1	SEE-Socio Econonic Status-Occup-Eng
Family Cohesion	1	FCE-Family Cohesion-Eng

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ICR Summary 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	470,709	17,284	0	453,425	0	0
Annual Time Burden (Hours)	74,386	5,309	0	69,077	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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: This is a revision of a currently approved information collection request for the second phase of the study, which will consist of a much shorter examination than baseline. Details of the specific changes are detailed in the in summary on page 1. The changes have resulted in a decrease in burden from 48,114 to 30,940.

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Annual Cost to Federal Government: $11,546,681

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]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

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: 07/17/2014

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