[Federal Register Volume 79, Number 135 (Tuesday, July 15, 2014)]
[Notices]
[Pages 41293-41295]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-16528]
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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). Three
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,
[[Page 41294]]
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). This component also includes contact
with physicians and informants to obtain medical information about
participants.
OMB approval is requested for 3 years. There are no costs to
respondents other than their time. The total estimated annualized
burden hours are 75,305.
Estimated Annualized Burden Hours
A.12.1 Estimates of Hour Burden
[Appendices 11, 14 and 15]
----------------------------------------------------------------------------------------------------------------
Number of Average time
Type of respondents Survey Number of responses per per response Total burden
instrument respondents respondent (in hours) hours
----------------------------------------------------------------------------------------------------------------
Participants Visit 2 Pre-visit 13878 1 2/60 463
Examination (Appendices 11 scheduling &
and 14). safety
screening
(Appendix 14 --
Procedures--ELE
bilingual).
Reception, 13878 1 20/60 4626
informed
consent
(Appendix 11),
medical
releases.
Ppt. disability 13878 1 4/60 925
screening.
Ppt. safety 13878 1 2/60 463
update and
routing
(Appendix 14--
Procedures--PSE
bilingual).
Change clothes, 13878 1 10/60 2313
urine specimen
(Appendix 14 --
Procedures --
BIO)*.
Updated personal 13878 1 5/60 1157
information.
Anthropometry... 13878 1 7/60 1619
Determination of 13878 1 11/60 2544
fasting & blood
draw (Appendix
14 --
Procedures--BIO
)*.
Determination of 13878 1 6/60 1388
blood glucose,
OGTT (Appendix
14 --
Procedures--BIO
)*.
Seated BP....... 13878 1 9/60 2082
Echocardiography 8000 1 30/60 4000
2-hour blood 13878 1 12/60 2776
draw, snack
(Appendix 14--
Procedures--BIO
)*.
Personal Medical 13878 1 10/60 2313
History.
Reproductive 9000 1 9/60 1350
Medical History.
Pregnancy 9000 1 6/60 900
Complications
History.
Socio-economic 13878 1 3/60 694
Status--Occupat
ion.
Health Care 13878 1 15/60 3470
Access and
Utilization.
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 4/60 925
Abbreviated 13878 1 4/60 925
Medication Use.
Tobacco Use..... 13878 1 7/60 1619
Alcohol Use..... 13878 1 3/60 694
Participant 13878 1 12/60 2776
Feedback.
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Total..................... ................ .............. 206/60 43492 ..............
----------------------------------------------------------------------------------------------------------------
Participants AFU Phone AFU Year 3...... 3146 1 15/60 787
Interview (Appendix 15).
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
[[Page 41295]]
AFU Year 11..... 16222 1 15/60 4055
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Total..................... ................ .............. 120/60 30940 ..............
----------------------------------------------------------------------------------------------------------------
Physicians and/or other health Hospitalization 1591 1 30/60 796
care providers. records/
physician
interview
(Appendix 16,
PQE).
Informants.................... Informant 154 1 30/60 77
Interview
Deaths
(Appendix 16,
IIE/IIS).
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Total..................... ................ .............. .............. 60/60 873
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Dated: June 18, 2014.
Michael Lauer,
Director, DCVS, NHLBI, NIH.
Dated: June 18, 2014.
Lynn Susulske,
NHLBI Project Clearance Liaison, National Institutes of Health.
[FR Doc. 2014-16528 Filed 7-14-14; 8:45 am]
BILLING CODE 4140-01-P