[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]


-----------------------------------------------------------------------

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]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                             Number of     Average  time
              Type of respondents                           Survey instrument                Number of     responses per   per  response   Total burden
                                                                                            respondents     respondent      (in hours)         hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
                                                                                         ---------------------------------------------------------------
    Total......................................  .......................................  ..............  ..............          206/60           43030
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
                                                                                         ---------------------------------------------------------------
    Total......................................  .......................................  ..............  ..............          120/60           30940
--------------------------------------------------------------------------------------------------------------------------------------------------------


    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