# Proposed Collection; 60-Day Comment Request; The Hispanic Community Health Study/Study of Latinos (HCHS/SOL) > Briefs, arguments, decisions, and more. URL: https://www.frixlaw.com/law-library/documents/fr%3A2014-06401 ## Record - **Collection:** Federal Register - **Document type:** Notice - **Published:** March 25, 2014 - **Citation:** 79 FR 16345 ## Text DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Proposed Collection; 60-Day Comment Request; The Hispanic Community Health Study/Study of Latinos (HCHS/SOL) SUMMARY: In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Heart, Lung and Blood Institute (NHLBI), National Institutes of Health (NIH), will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. To Submit Comments and For Further Information: To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: 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 avilessantal@nhlbi.nih.gov . Formal requests for additional plans and instruments must be requested in writing. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. Proposed Collection: The Hispanic Community Health Study/Study of Latinos (HCHS/SOL), Revised, 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. Estimated Annualized Burden Hours Type of respondents Survey instrument Number of respondents Number of responses per respondent Average time per response (in hours) Total burden hours Participants Visit 2 Examination (Appendix 15) Pre-visit scheduling & safety screening 13,878 1 2/60 463 Reception, informed consent, medical releases 13,878 1 20/60 4,626 Ppt. safety update and routing 13,878 1 2/60 463 Change clothes, urine specimen 13,878 1 10/60 2,313 Updated personal information 13,878 1 5/60 1,157 Anthropometry 13,878 1 7/60 1,619 Determination of fasting & blood draw 13,878 1 11/60 2,544 Determination of blood glucose, OGTT 13,878 1 6/60 1,388 Seated BP 13,878 9/60 2,082 Echocardiography 8,000 30/60 4,000 2-hour blood draw, snack 13,878 12/60 2,776 Personal Medical History 13,878 1 10/60 2,313 Reproductive Medical History 9,000 1 9/60 1,350 Pregnancy Complications History 9,000 1 4/60 600 Socio-economic Status—Occupation 13,878 1 3/60 694 Health Care Access and Utilization 13,878 1 15/60 3,470 Chronic Stress 13,878 1 4/60 925 Family Cohesion 13,878 1 5/60 1,157 Social Support 13,878 1 3/60 694 Acculturation 13,878 1 3/60 694 Well Being 13,878 1 4/60 463 Abbreviated Medication Use 13,878 1 4/60 925 Tobacco Use 13,878 1 4/60 925 Alcohol Use 13,878 1 3/60 694 Participant Feedback 13,878 1 12/60 2,776 Total 197/60 41,111 Participants Annual Follow-Up Interview (Appendix 16) AFU Year 3 3,146 1 15/60 787 AFU Year 4 9,033 1 15/60 2,258 AFU Year 5 14,259 1 15/60 3,565 AFU Year 6 16,222 1 15/60 4,055 AFU Year 7 16,222 1 15/60 4,055 AFU Year 8 16,222 1 15/60 4,055 AFU Year 9 16,222 1 15/60 4,055 AFU Year 10 16,222 1 15/60 4,055 AFU Year 11 16,222 1 15/60 4,055 Total 120/60 30,940 Dated: March 11, 2014. Michael Lauer, Director, DCVS, NHLBI, NIH. Dated: March 11, 2014. Lynn Susulske, NHLBI Project Clearance Liaison, National Institutes of Health. [FR Doc. 2014-06401 Filed 3-24-14; 8:45 am] BILLING CODE 4140-01-P --- Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A2014-06401. Public record. Not legal advice.