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

Forms and Documents

Document Name	Status
Form 3 Participants Follow-up Year 3 to 6 Form and Instruction	New
Form 1 Food Propensity Form and Instruction	Removed
Form 11 Focus Groups Form and Instruction	Removed
Form 1 Non Participant Components Form and Instruction	Modified
Form 1 Participant Telephone Interviews Form and Instruction	Removed
Form 1 Clinic Questionaires Form and Instruction	Removed
Form 11 Clinic Exam Procedures Form and Instruction	Removed
Form 2 Participants Follow-up Year 2 Form and Instruction	Modified
Form 1 Participants Follow-up Year 1 Form and Instruction	Modified
Final HCHS. B. Supporting Statement.11.23.11.docx Supporting Statement B	2011-11-30
UNC_Approval_03-2011.pdf Supplementary Document	2011-10-07
San Diego_Talavera_ HIPPA_English.pdf Supplementary Document	2011-10-07
San Diego_Talavera_3677_SOL_IRB Renewal .pdf Supplementary Document	2011-10-07
Miami_HIPAA_Form_English.pdf Supplementary Document	2011-10-07
Miami_HCHS IRB Continuing Approval letter 041511 (2).pdf Supplementary Document	2011-10-07
Albert Einstein HIPPA_Updated English HIPAA .pdf Supplementary Document	2011-10-07
Albert Einstein COM HCHS IRB approval_012011.pdf Supplementary Document	2011-10-07
Northwestern Univ_Approval HCHS 2010-2011.pdf Supplementary Document	2011-10-07
8. HCHS budget.xlsm Supplementary Document	2011-10-07
7. HCHS Privacy Policy.docm Supplementary Document	2011-10-07
6. OSMB Minutes.2010.pdf Supplementary Document	2011-10-07
5. NHLBI Council Minutes.2004.docm Supplementary Document	2011-10-07
4.Working Group Report Aug 11 2010.doc Supplementary Document	2011-10-07
3. Epidemiologic Research in Hispanic Populations2003.docm Supplementary Document	2011-10-07
2. Timeline for Annual Follow.ps.doc Supplementary Document	2011-10-07
1. Privacy Act Memo.pdf Supplementary Document	2011-10-07
Final.HCHS.A. Supporting Statement.11.23.11.docx Supporting Statement A	2011-11-30

IC Document Collections

IC ID	Document Title	Status
199868	Participants Follow-up Year 3 to 6 Form and Instruction	New
187780	Food Propensity Form and Instruction	Removed
183722	Focus Groups Form and Instruction	Removed
182193	Non Participant Components Form and Instruction	Modified
182192	Participant Telephone Interviews Form and Instruction	Removed
182191	Clinic Questionaires Form and Instruction	Removed
182190	Clinic Exam Procedures Form and Instruction	Removed
182189	Participants Follow-up Year 2 Form and Instruction	Modified
182188	Participants Follow-up Year 1 Form and Instruction	Modified

ICR Details

OMB Control No: 0925-0584	ICR Reference No: 201110-0925-002
Status: Historical Active	Previous ICR Reference No: 200901-0925-003
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 with change	Conclusion Date: 12/12/2011
	Date Received in OIRA: 10/24/2011
Terms of Clearance: Previous terms of clearance continue: 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	12/31/2014	36 Months From Approved	03/31/2012
Responses	17,284	0	66,640
Time Burden (Hours)	5,309	0	48,114
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 relationship 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:
	76 FR 48872	08/09/2011
30-day Notice:	Federal Register Citation:	Citation Date:
	76 FR 64357	10/18/2011
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 4

IC Title	Form No.	Form Name
Participants Follow-up Year 1	1	Interview
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
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
Clinic Exam Procedures	1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21	Occupation ,   Oral Health ,   Personal Information ,   Physical Activity ,   Respiratory ,   SF 12 ,   Social Cultural ,   Tobacco Use ,   Weight History ,   Well Being ,   Sleep ,   Medical History ,   Medication Use ,   Neuro ,   Alcohol Use ,   Dietary Recall and Supplement Use ,   Dietary Behavior ,   Economic ,   Health Care Use ,   Hearing Exam ,   Informed Consent
Clinic Questionaires	8, 9, 10, 11, 12, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 3, 5, 6, 7, 4, 1, 2	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
Participant Telephone Interviews	1, 3, 2, 5, 6, 4, 7	Recall ,   Informant ,   survey ,   survey ,   survey ,   survey ,   survey
Food Propensity	1	survey

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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	17,284	66,640	0	-49,356	0	0
Annual Time Burden (Hours)	5,309	48,114	0	-42,805	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: Changing Forms

Short Statement: With this modification that covers continued annual follow-up of participants, the overall burden hours requested have been reduced to a total of 5,309 hours.

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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]? 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: 10/24/2011

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