Proposed Collection; 60-Day Comment Request: The Framingham Heart Study (FHS)

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health

Proposed Collection; 60-Day Comment Request: The Framingham Heart Study (FHS)

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), the 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 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) 435-0456, or email your request, including your address to:

weig@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 Framingham Heart Study, 0925-0216, Extension, 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.

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:

1

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.)

Dated: April 25, 2013.

Lynn Susulske,

NHLBI Project Clearance Liaison, National Institutes of Health.

Michael Lauer,

Director, DCVS, National Institutes of Health.

[FR Doc. 2013-10771 Filed 5-6-13; 8:45 am]

BILLING CODE 4140-01-P