E7-17986. Submission for OMB Review; Comment Request; The Hispanic Community Health Study (HCHS)/Study of Latinos (SOL)

SUMMARY:

Under the provisions of section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Heart, Lung, and Blood Institute (NHLBI), 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 July 11, 2007, pages 37789-37790, and allowed 60-days for public comment. No comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The 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.

Proposed Collection: Title: Hispanic Community Health Study (HCHS)/ Study of Latinos (SOL).

Type of Information Collection Request: New Collection. Need and Use of Information Collection: The Hispanic Community Health Study (HCHS)/ Study of Latinos (SOL) will identify risk factors for cardiovascular and lung disease in Hispanic populations and determine the role of acculturation in the prevalence and development of these diseases. Hispanics, now the largest minority population in the US, are influenced by factors associated with immigration from different cultural settings and environments, including changes in diet, activity, community support, working conditions, and health care access. This project is a multicenter, six-and-a-half year epidemiologic study and will recruit 16,000 Hispanic men and women aged 18-74 in four community-based cohorts in Chicago, Miami, San Diego, and the Bronx. The study will also examine measures of obesity, physical activity, nutritional habits, diabetes, lung and sleep function, cognitive function, hearing, and dental conditions. Closely integrated with the research component will be a community and professional education component, with the goals of bringing the research results back to the community, improving recognition and control of risk factors, and attracting and training Hispanic researchers in epidemiology and population-based research.

Frequency of Response: The participants will be contacted annually. Affected Public: Individuals or households; Businesses or other for profit; Small businesses or organizations. Type of Respondents: Individuals or households; physicians. The annual reporting burden is as follows: Estimated Number of Respondents: 39,844; Estimated Number of Responses per Respondent: 1.0; Average Burden Hours Per Response: 1.1; and Estimated Total Annual Burden Hours Requested: 44,688. The annualized cost to respondents is estimated at $149,415, assuming respondents time at the rate of $15 per hour and physician time at the rate of $55 per hour. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report.

Table A.12.1.—Estimate of Respondent Burden HCHS/SOL

Type of response	Number of respondents	Number of responses	Time per response (hours)	Burden (hours)
a. Recruitment contacts	22,369	1	0.08	1,790
b. Household enumeration	4,191	1	0.17	712
c. Telephone contact to set up appointment	6,667	1	0.08	533
d. Appointment Confirmation	6,667	1	0.08	533
e. CLINIC EXAM:
e1. Procedures	5,333	1	3.67	19,572
e2. Questionnaires	5,333	1	2.75	14,666
f. Participant Telephone Interviews:
24-hour Dietary Intake Recall	5,333	1	0.67	3,573
Follow-Up Call	5,333	1	0.50	2,667
Total, Participant	38,560			44,046
Non-participant components: 1
a. Physician, hospital and nursing home contacts for outcomes ascertainment (total = 1,254):
Deaths	60	1	0.50	627
CHF	90
Stroke	132
CHD	650
COPD	210
Asthma	112
b. Informant contact	30	1	0.50	15
Total, Participant and Non-Participant Components	39,844			44,688
1 Annual burden is place on physicians and health care providers and respondent relatives/informants through request for information which will help in the compilation of the number and nature of new fatal and non-fatal events.

Request for Comments: Written comments and/or suggestions from the public and affected agencies should address one or more of the following points: (1) Evaluate 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) Evaluate 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) Enhance the quality, utility, and clarity of the information to be collected; and (4) 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.

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, New Executive Office Building, Room 10235, Washington, DC 20503, Attention: Desk Officer for NIH. To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact: Dr. Larissa Aviles-Santa, Deputy Project Officer, NIH, NHLBI, 6701 Rockledge Drive, MSC 7936, Bethesda, MD 20892-7936, or call non-toll-free number 301-435-1284 or E-mail your request, including your address to: [e-mail].

Comments 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.

Dated: September 7, 2007.

Mike Lauer,

Director, Division of Prevention and Population Sciences, NHLBI, National Institutes of Health.

Dated: September 7, 2007.

Suzanne Freeman,

Chief, FOIA, NHLBI, National Institutes of Health.