2014-18145. Submission for OMB Review; 30-Day Comment Request; Recruitment and Screening for the Insight Into Determination of Exceptional Aging and Longevity (IDEAL) Study

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 April 2, 2014, Vol. 79, page 18569 and allowed 60-days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Institute on Aging (NIA), 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, [e-mail] 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 obtain a copy of the data collection plans and instruments or request more information on the proposed project contact: Luigi Ferrucci, M.D., Ph.D., NIA Clinical Research Branch, Harbor Hospital, 5th Floor, 3001 S. Hanover, Baltimore, MD 21225 or call non-toll-free number [phone] or Email your request, including your address to: [e-mail]. Formal requests for additional plans and instruments must be requested in writing.

Proposed Collection: Recruitment and Screening for the Insight into Determination of Exceptional Aging and Longevity (IDEAL) Study (OMB#: 0925-0631). National Institute on Aging (NIA), National Institutes of Health (NIH).

Need and Use of Information Collection

Longevity combined with good health and functionality at the end of life represents a common goal. Although research has examined correlates of long life and functional decline, we still know relatively little about why certain individuals live in excellent health into their eighties while others succumb to failing health at much younger ages. Understanding the mechanisms important to ideal aging may provide new opportunity for health promotion and disability prevention is this rapidly growing segment of the population.

The purpose of IDEAL (Insight into the Determinants of Exceptional Aging and Longevity) is to recruit into the Baltimore Longitudinal Study on Aging (BLSA) exceptionally long lived and healthy individuals and to learn what makes them so resilient and resistant to disease and disability, and to identify potential interventions that may contribute to the IDEAL condition. By enrolling the IDEAL cohort in the BLSA their biologic, physiologic, behavioral and functional characteristics will be evaluated using the same methods used with the current cohort who will serve as a type of control group. The first aim is to identify factors and characteristics that distinguish IDEAL from non-IDEAL individuals. We intend to compare the two groups to identify factors that discriminate IDEAL aging from non-IDEAL aging individuals. The second aim is to identify physiological, environmental and behavioral characteristics that are risk factors for losing the IDEAL condition over several years or longer. We postulate that the mechanisms of extreme longevity probably differ from those associated with delay or escape from disease and disability. As is customary in the BLSA, we plan to follow this cohort for life with yearly visits. This is a request for OMB to approve a reinstatement with change of Recruitment and Screening for the Insight into Determination of Exceptional Aging and Longevity (IDEAL) Study for 3 years.

OMB approval is requested for 3 years. There is no annualized cost to respondents. The total estimated annualized burden hours are 333.

Estimated Annualized Burden Hours

Type of respondent	Form name	Estimated annual number of respondents	Number of responses per respondent	Average time per response (in hours)	Total annual burden hours
Individuals	Recruitment Phone Screen Part 1	500	1	10/60	83
Individuals	Recruitment Phone Screen Part 2	200	1	10/60	33
Individuals	Pre-Visit mailing/Consent	100	1	10/60	17
Individuals	Screening Exam Visit	100	1	2	200

Dated: July 23, 2014.

Jessica Schwartz,

NIA Project Clearance Liaison, National Institutes of Health.