[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
----------------------------------------------------------------------------------------------------------------
                                                                     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                 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.
                                                 ---------------------------------------------------------------
    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
----------------------------------------------------------------------------------------------------------------



[[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