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

Forms and Documents

Document Name	Status
Form 20 Focus Groups Form and Instruction	New
Form 1 Non Participant Components Form and Instruction	New
Form 1 Participant Telephone Interviews Form and Instruction	New
Form 4 Clinic Questionaires Form and Instruction	New
Form 1 Clinic Exam Procedures Form and Instruction	New
Form 1 Household Enumeration Form and Instruction	New
Form 1 Recruitment Contact and Appoinment Confirmation Form and Instruction	New
Xwalk_rev_12-20-07.doc Supplementary Document	2008-02-11
Timeline - Hispanic Community Health Study.doc Supplementary Document	2008-02-11
Protocol.source.doc Supplementary Document	2008-02-11
Personal Information QxQ_1-29-08.doc Supplementary Document	2008-02-11
OMB budget repspone brf.1-31-08.xls Supplementary Document	2008-02-11
Examples of QXQs.doc Supplementary Document	2008-02-11
Council-Oct.04.pdf Supplementary Document	2008-02-11
Combined Response.Hispanic Survey - Response to OMB Questions - OMB passback2.doc Supplementary Document	2008-02-11
CC. HIPAA Form - Revised 1-25-08.doc Supplementary Document	2008-02-11
Attachments-OMB Passback2.doc Supplementary Document	2008-02-11
Revised B Supporting Statement 2.8.08.doc Supporting Statement B	2008-02-11
Well being_span.doc Supplementary Document	2007-09-13
Weight History_span.doc Supplementary Document	2007-09-13
Socio cultural_span.doc Supplementary Document	2007-09-13
Social Network Index_span.doc Supplementary Document	2007-09-13
Sleep_span.doc Supplementary Document	2007-09-13
SF12_span.doc Supplementary Document	2007-09-13
Screen and Roster_span.doc Supplementary Document	2007-09-13
Respiratory_span.doc Supplementary Document	2007-09-13
Resident Response_span.doc Supplementary Document	2007-09-13
Physical Activity_span.doc Supplementary Document	2007-09-13
Tobacco Use_span.doc Supplementary Document	2007-09-13
Personal Information_span.doc Supplementary Document	2007-09-13
Personal Identifiers_span.doc Supplementary Document	2007-09-13
Oral Health_span.doc Supplementary Document	2007-09-13
Phone_script_span.doc Supplementary Document	2007-09-13
Occupation_span.doc Supplementary Document	2007-09-13
Neurocognitive Assessment_span.doc Supplementary Document	2007-09-13
Medication Use_span.doc Supplementary Document	2007-09-13
Medical History_span.doc Supplementary Document	2007-09-13
Introductory letter_span.doc Supplementary Document	2007-09-13
Informed Consent_span.doc Supplementary Document	2007-09-13
Hearing History_span.doc Supplementary Document	2007-09-13
Hearing Exam_span.doc Supplementary Document	2007-09-13
Health Care Use_span.doc Supplementary Document	2007-09-13
Economic_span.doc Supplementary Document	2007-09-13
Diet and Supplement In-Person Recall_span.doc Supplementary Document	2007-09-13
Diet and Supplement Phone Script Recall_span.doc Supplementary Document	2007-09-13
In-person script_span.doc Supplementary Document	2007-09-13
Appointment Reminder call_09-12-07_span.doc Supplementary Document	2007-09-13
Alcohol Use_span.doc Supplementary Document	2007-09-13
Brochure-Span.pdf Supplementary Document	2007-09-13
San Diego.IRB..doc Supplementary Document	2008-02-11
UNC_HCHS_Coordinating Center_IRB 2007.pdf Supplementary Document	2007-09-13
Bronx_IRB. Sep_ 11. 2007 (2).pdf Supplementary Document	2007-09-13
MIAMI.IRB pending.doc Supplementary Document	2007-09-13
Northwestern_IRB_approval.pdf Supplementary Document	2007-09-13
Privacy Policy.doc Supplementary Document	2007-09-13
Privacy Act.doc Supplementary Document	2007-09-13
Responses to OMB comments 5-7-07.doc Supplementary Document	2007-09-13
OSMB Minutes.doc Supplementary Document	2007-09-13
Epidemiologic Research in Hispanic Populations.doc Supplementary Document	2007-09-13
Council Minutes.doc Supplementary Document	2007-09-13
Legislative Mandate.pdf Supplementary Document	2007-09-13
Revised A Supporting Statement.2.08.08.doc Supporting Statement A	2008-02-11

IC Document Collections

IC ID	Document Title	Status
183722	Focus Groups Form and Instruction	New
182193	Non Participant Components Form and Instruction	New
182192	Participant Telephone Interviews Form and Instruction	New
182191	Clinic Questionaires Form and Instruction	New
182190	Clinic Exam Procedures Form and Instruction	New
182189	Household Enumeration Form and Instruction	New
182188	Recruitment Contact and Appoinment Confirmation Form and Instruction	New

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
	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.).

	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

---

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.

---

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

Citations for New Statutory Requirements: None

---

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

---

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

---

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

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

---

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	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.

---

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

---

Common Form ICR:  No

---

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

---