Submission for OMB Review; 30-day Comment Request: The Framingham Heart Study (FHS)

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health

Submission for OMB Review; 30-day Comment Request: The Framingham Heart Study (FHS)

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 May 7, 2013, pages 26639-41 and allowed 60-days for public comment. No public comments were received. 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,

OIRA_submission@omb.eop.gov

or by fax to 202-395-6974, Attention: NIH Desk Officer.

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 request more information on the proposed project or to obtain a copy of data collection plans and instruments, contact Dr. Gina Wei, Division of Cardiovascular Sciences, NHLBI, NIH, Two Rockledge Center, 6701 Rockledge Drive, MSC 7936, Bethesda, MD, 20892-7936, or call non-toll-free number (301) 435-0416, or email your request, including your address to:

weig@nhlbi.nih.gov.

Formal requests for additional plans and instruments must be requested in writing.

Proposed Collection:

The Framingham Heart Study, 0925-0216, Revision National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH).

Need and Use of Information Collection:

The Framingham Heart Study will continue to conduct morbidity and mortality follow-up, as well as examinations, for the purpose of studying the determinants of cardiovascular disease. Morbidity and mortality follow-up will continue to occur in all of the cohorts (Original, Offspring, Third Generation, Omni Group 1, and Omni Group 2). Examinations will continue to be conducted on the Original, Offspring, and Omni Group 1 Cohorts. The numbers of Offspring and Omni Group 1 participants to be examined for this OMB submission are much smaller than those during the last OMB approval period. This is because a great majority of these two cohorts have already completed their examinations. The small number of participants remaining to be examined is reflected in the decrease in the estimated annualized burden hours for these two cohorts as well as for the entire study, compared to the last OMB approval period.

OMB approval is requested for 3 years. There is no cost to the respondents other than their time. The total estimated annualized burden hours are 4264.

Estimated Annualized Burden Hours, Original Cohort

Type of respondent

Number of

respondents

Number of

responses per respondent

Average time per response

(in hours)

Total annual

burden hour

I. PARTICIPANT COMPONENTS

A. PRE-EXAM:

a. Telephone contact to set up appointment

60

1

10/60

10

b. Exam Appointment, Scheduling, Reminder, and Instructions

55

1

35/60

32

B. EXAM—Cycle 32:

a. Clinic exam

25

1

45/60

19

b. Home or nursing home visit

25

1

65/60

27

C. ANNUAL FOLLOW-UP:

a. Records Request

60

1

15/60

15

b. Health Status Update

45

1

15/60

11

SUB-TOTAL: PARTICIPANT COMPONENTS

*60

114

II. NON-PARTICIPANT COMPONENTS

A. Informant Contact (Pre-exam and Annual Follow-up)

25

1

10/60

4

B. Records Request (Annual follow-up)

50

1

15/60

13

SUB-TOTAL: NON-PARTICIPANT COMPONENTS

75

17

* Number of participants as reflected in Rows I.A.a and I.C.a. above

Estimated Annualized Burden Hours, Offspring Cohort and Omni Group 1 Cohort

Type of respondent

Number of

respondents

Number of

responses per respondent

Average time per response

(in hours)

Total annual

burden hour

I. PARTICIPANT COMPONENTS

A. PRE-EXAM:

a. Telephone contact to set up apt or Health status update

300

1

10/60

50

b. Appt. or update Confirmation

250

1

10/60

42

c. Food Frequency Form

250

1

10/60

42

B. EXAM:

a. Clinic Exam

100

1

175/60

292

b. Home or nursing home visit

100

1

60/60

100

c. Consent Forms

200

1

20/60

67

C. ANNUAL FOLLOW-UP:

a. Records Request

2292

1

15/60

573

b. Health Status Update

1833

1

15/60

458

SUB-TOTAL: PARTICIPANT COMPONENTS

*2292

1624

II. NON-PARTICIPANT COMPONENTS

A. Informant contact (Pre-exam and Annual Follow-up)

229

1

10/60

38

B. Records Request (Annual follow-up)

2292

1

15/60

573

SUB-TOTAL: NON-PARTICIPANT COMPONENTS

2521

611

* Number of participants as reflected in Rows I.C.a. above.

Estimated Annualized Burden Hours, Generation 3 Cohort and Omni Group 2 Cohort

Type of respondent

Number of

respondents

Number of

responses per respondent

Average time per response

(in hours)

Total annual burden hour

I. PARTICIPANT COMPONENTS—ANNUAL FOLLOW-UP

A. Records Request

3212

1

15/60

803

B. Health Status Update

3212

1

15/60

803

SUB-TOTAL: PARTICIPANT COMPONENTS

* 3212

1606

II. NON-PARTICIPANT COMPONENTS—ANNUAL FOLLOW-UP

A. Informant contacts

160

1

10/60

27

B. Records Request

1060

1

15/60

265

SUB-TOTAL: NON-PARTICIPANT COMPONENTS

1220

292

* Number of participants as reflected in Rows I.A. and I.B. above.

Summary of 3 Tables Combined—Total Estimated Annualized Burden Hours

Type of respondent

Number of respondents

Number of responses per respondent

Average time per response

(in hours)

Total annual burden hour

Participants

5564

1

36/60

3344

Non-Participants

3816

1

14.5/60

920

Totals

9380

4264

(

Note:

reported and calculated numbers differ slightly due to rounding.)

Lynn Susulske,

NHLBI Project Clearance Liaison, National Institutes of Health.

Michael Lauer,

Director, DCVS, National Institutes of Health.

[FR Doc. 2013-23060 Filed 9-20-13; 8:45 am]

BILLING CODE 4140-01-P