[Federal Register Volume 79, Number 57 (Tuesday, March 25, 2014)]
[Notices]
[Pages 16345-16347]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-06401]
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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 [email protected]. Formal requests
for additional plans and
[[Page 16346]]
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
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Number of Average time
Type of respondents Survey Number of responses per per response Total burden
instrument respondents respondent (in hours) hours
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Participants Visit 2 Pre-visit 13,878 1 2/60 463
Examination (Appendix 15). scheduling &
safety
screening.
Reception, 13,878 1 20/60 4,626
informed
consent,
medical
releases.
Ppt. safety 13,878 1 2/60 463
update and
routing.
Change clothes, 13,878 1 10/60 2,313
urine specimen.
Updated personal 13,878 1 5/60 1,157
information.
Anthropometry... 13,878 1 7/60 1,619
Determination of 13,878 1 11/60 2,544
fasting & blood
draw.
Determination of 13,878 1 6/60 1,388
blood glucose,
OGTT.
Seated BP....... 13,878 .............. 9/60 2,082
Echocardiography 8,000 .............. 30/60 4,000
2-hour blood 13,878 .............. 12/60 2,776
draw, snack.
Personal Medical 13,878 1 10/60 2,313
History.
Reproductive 9,000 1 9/60 1,350
Medical History.
Pregnancy 9,000 1 4/60 600
Complications
History.
Socio-economic 13,878 1 3/60 694
Status--Occupat
ion.
Health Care 13,878 1 15/60 3,470
Access and
Utilization.
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 13,878 1 4/60 925
Medication Use.
Tobacco Use..... 13,878 1 4/60 925
Alcohol Use..... 13,878 1 3/60 694
Participant 13,878 1 12/60 2,776
Feedback.
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Total..................... ................ .............. .............. 197/60 41,111
Participants Annual Follow-Up AFU Year 3...... 3,146 1 15/60 787
Interview.
(Appendix 16).................
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
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[[Page 16347]]
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