Proposed Collection; 60-Day Comment Request; The Hispanic Community Health Study/Study of Latinos (HCHS/SOL)

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

avilessantal@nhlbi.nih.gov

. Formal requests for additional plans and

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

Type of respondents

Survey instrument

Number of

respondents

Number of

responses per respondent

Average time per response

(in hours)

Total burden hours

Participants Visit 2 Examination (Appendix 15)

Pre-visit scheduling & safety screening

13,878

1

2/60

463

Reception, informed consent, medical releases

13,878

1

20/60

4,626

Ppt. safety update and routing

13,878

1

2/60

463

Change clothes, urine specimen

13,878

1

10/60

2,313

Updated personal information

13,878

1

5/60

1,157

Anthropometry

13,878

1

7/60

1,619

Determination of fasting & blood draw

13,878

1

11/60

2,544

Determination of blood glucose, OGTT

13,878

1

6/60

1,388

Seated BP

13,878

9/60

2,082

Echocardiography

8,000

30/60

4,000

2-hour blood draw, snack

13,878

12/60

2,776

Personal Medical History

13,878

1

10/60

2,313

Reproductive Medical History

9,000

1

9/60

1,350

Pregnancy Complications History

9,000

1

4/60

600

Socio-economic Status—Occupation

13,878

1

3/60

694

Health Care Access and Utilization

13,878

1

15/60

3,470

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 Medication Use

13,878

1

4/60

925

Tobacco Use

13,878

1

4/60

925

Alcohol Use

13,878

1

3/60

694

Participant Feedback

13,878

1

12/60

2,776

Total

197/60

41,111

Participants Annual Follow-Up Interview

(Appendix 16)

AFU Year 3

3,146

1

15/60

787

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

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