[Federal Register Volume 79, Number 117 (Wednesday, June 18, 2014)]
[Notices]
[Pages 34767-34768]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-14258]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; 30-Day Comment Request--the Hispanic
Community Health Study/Study of Latinos (HCHS/SOL)
SUMMARY: 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, [email protected] or by fax to 202-395-6974,
Attention: NIH Desk Officer.
DATES: 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.
FOR FURTHER INFORMATION CONTACT: 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
[email protected]. 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.
[[Page 34768]]
Estimated Annualized Burden Hours
A.12.1 Estimates of Hour Burden
[Appendices 11, 14 and 15]
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Number of Average time
Type of respondents Survey instrument Number of responses per per response Total burden
respondents respondent (in hours) hours
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Participants Visit 2 Examination (Appendices 11 Pre-visit scheduling & safety screening 13878 1 2/60 463
and 14).
Reception, informed consent (Appendix 13878 1 20/60 4626
11), medical releases.
Ppt. disability screening.............. 13878 1 4/60 925
Ppt. safety update and routing......... 13878 1 2/60 463
Change clothes, urine specimen......... 13878 1 10/60 2313
Updated personal information........... 13878 1 5/60 1157
Anthropometry.......................... 13878 1 7/60 1619
Determination of fasting & blood draw.. 13878 1 11/60 2544
Determination of blood glucose, OGTT... 13878 1 6/60 1388
Seated BP.............................. 13878 1 9/60 2082
Echocardiography....................... 8000 1 30/60 4000
2-hour blood draw, snack............... 13878 1 12/60 2776
Personal Medical History............... 13878 1 10/60 2313
Reproductive Medical History........... 9000 1 9/60 1350
Pregnancy Complications History........ 9000 1 6/60 900
Socio-economic Status--Occupation...... 13878 1 3/60 694
Health Care Access and Utilization..... 13878 1 15/60 3470
Chronic Stress......................... 13878 1 4/60 925
Family Cohesion........................ 13878 1 5/60 1157
Social Support......................... 13878 1 3/60 694
Acculturation.......................... 13878 1 3/60 694
Well Being............................. 13878 1 4/60 463
Abbreviated Medication Use............. 13878 1 4/60 925
Tobacco Use............................ 13878 1 7/60 1619
Alcohol Use............................ 13878 1 3/60 694
Participant Feedback................... 13878 1 12/60 2776
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Total...................................... ....................................... .............. .............. 206/60 43030
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Participants AFU Phone Interview (Appendix 15). AFU Year 3............................. 3146 1 15/60 787
AFU Year 4............................. 9033 1 15/60 2258
AFU Year 5............................. 14259 1 15/60 3565
AFU Year 6............................. 16222 1 15/60 4055
AFU Year 7............................. 16222 1 15/60 4055
AFU Year 8............................. 16222 1 15/60 4055
AFU Year 9............................. 16222 1 15/60 4055
AFU Year 10............................ 16222 1 15/60 4055
AFU Year 11............................ 16222 1 15/60 4055
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Total...................................... ....................................... .............. .............. 120/60 30940
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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.
[FR Doc. 2014-14258 Filed 6-17-14; 8:45 am]
BILLING CODE 4140-01-P