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Proposed Collection; 30-Day Comment Request-the Hispanic Community Health Study/Study of Latinos (HCHS/SOL)

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Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on March 25, 2014 (Vol. 79, No. 57, pages 16345-16347). 3 comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Heart, Lung and Blood Institute (NHLBI), National Institutes of Health, may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number.

Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, or by fax to 202-395-6974, Attention: NIH Desk Officer.


Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30-days of the date of this publication.

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To obtain a copy of the data collection plans and instruments or request more information on the proposed project contact either: Dr. Larissa Aviles-Santa, 6701 Rockledge, Epidemiology Branch, Program in Prevention and Population Sciences, Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, National Institutes of Health, 6701 Rockledge Dr., MSC 7936, Bethesda, MD 20892-7936, or call non-toll-free number 301-435-0450, or Email your request, including your address to Formal requests for additional plans and instruments must be requested in writing.

Proposed Collection: The Hispanic Community Health Study/Study of Latinos (HCHS/SOL), Revision, National Heart, Lung and Blood Institute (NHLBI), National Institutes of Health (NIH).

Need and Use of Information Collection: The purpose and use of the information collection for this project is to study the prevalence of cardiovascular and pulmonary disease and other chronic diseases, and their risk and protective factors, understand their relationship to all-cause, cardiovascular and pulmonary morbidity and mortality, and understand the role of sociocultural factors (including acculturation) on the prevalence or onset of disease among over 16,400 Hispanics/Latinos of diverse origins, aged 18-74 years at enrollment, living in four U.S. communities: San Diego, California; Chicago, Illinois; Miami, Florida, and the Bronx, New York. In order to achieve these objectives, the HCHS/SOL had two integrated components:

1. Examination of the cohort following a standardized protocol, which consisted of interviews and clinical measurements to assess physiological and biochemical measurements including DNA/RNA extraction for ancillary genetic research studies.

2. Follow-up of the cohort, which consists of an annual telephone interview to assess vital status, changes in health status and medication intake, and new cardiovascular and pulmonary events (including fatal and non-fatal myocardial infarction and heart failure; fatal and non-fatal stroke; and exacerbation of asthma and chronic obstructive pulmonary disease).

OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 30,940.Start Printed Page 34768

Estimated Annualized Burden Hours

A.12.1 Estimates of Hour Burden

[Appendices 11, 14 and 15]

Type of respondentsSurvey instrumentNumber of respondentsNumber of responses per respondentAverage time per response (in hours)Total burden hours
Participants Visit 2 Examination (Appendices 11 and 14)Pre-visit scheduling & safety screening1387812/60463
Reception, informed consent (Appendix 11), medical releases13878120/604626
Ppt. disability screening1387814/60925
Ppt. safety update and routing1387812/60463
Change clothes, urine specimen13878110/602313
Updated personal information1387815/601157
Determination of fasting & blood draw13878111/602544
Determination of blood glucose, OGTT1387816/601388
Seated BP1387819/602082
2-hour blood draw, snack13878112/602776
Personal Medical History13878110/602313
Reproductive Medical History900019/601350
Pregnancy Complications History900016/60900
Socio-economic Status—Occupation1387813/60694
Health Care Access and Utilization13878115/603470
Chronic Stress1387814/60925
Family Cohesion1387815/601157
Social Support1387813/60694
Well Being1387814/60463
Abbreviated Medication Use1387814/60925
Tobacco Use1387817/601619
Alcohol Use1387813/60694
Participant Feedback13878112/602776
Participants AFU Phone Interview (Appendix 15)AFU Year 3 AFU Year 43146 90331 115/60 15/60787 2258
AFU Year 514259115/603565
AFU Year 616222115/604055
AFU Year 716222115/604055
AFU Year 816222115/604055
AFU Year 916222115/604055
AFU Year 1016222115/604055
AFU Year 1116222115/604055
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Dated: June 5, 2014.

Michael Lauer,

Director, DCVS, NHLBI, NIH.

Dated: June 5, 2014.

Lynn Susulske,

NHLBI Project Clearance Liaison, National Institutes of Health.

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[FR Doc. 2014-14258 Filed 6-17-14; 8:45 am]