[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.
                               ---------------------------------------------------------------------------------
    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
                               ---------------------------------------------------------------------------------
    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).
                               ---------------------------------------------------------------------------------
    Total.....................  ................  ..............  ..............           60/60             873
----------------------------------------------------------------------------------------------------------------


    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