81 FR 115 pgs. 39058-39059 - Submission for OMB Review; 30-Day Comment Request; Women's Health Initiative (NHLBI)
Type: NOTICEVolume: 81Number: 115Pages: 39058 - 39059
Pages: 39058, 39059FR document: [FR Doc. 2016-14057 Filed 6-14-16; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: National Institutes of Health
Official PDF Version: PDF Version
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day Comment Request; Women's Health Initiative (NHLBI)
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 4, 2016, Pages: 19207-19208. No comments were received. The purpose of this notice is to allow an additional 30 days for public comment. 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 obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Shari Ludlam, 6701 Rockledge Drive, MSC 7936, Bethesda, MD 20892, or call non-toll-free number (301) 435-6667, or Email your request to: ludlams@mail.nih.gov. Formal requests for additional plans and instruments must be requested in writing.
Proposed Collection: The Women's Health Initiative, 0925-0414, Revision, Exp. 7/31/2016, National Heart, Lung, and Blood Institute (NHLBI), the National Institutes of Health (NIH).
[top] Need and Use of Information Collection: This proposal is to extend the Women's Health Initiative (WHI), which comprises a group of research studies that will address critical issues about the most common causes of frailty, disability, and death among post-menopausal women aged 50 to 79 years. This Initiative is comprised of two main investigational approaches: (1) A large clinical trial (CT) to evaluate the clinical efficacy of promising, but unproven preventive approaches for specific diseases common among older women; and (2) a companion observational study (OS) comprised of women ineligible or unwilling to participate in the CT, to evaluate risk factors for chronic diseases by following this large cohort of women and relating subsequent disease development to baseline assessments of historical,
OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 10,796.
| Form name | Type of respondent | Number of respondents | Number of responses per respondent | Average burden per response (in hours) | Total annual burden hours |
|---|---|---|---|---|---|
| Medical History Update | Participants | 40,203 | 1 | 7/60 | 4,690 |
| Activities of Daily Life | Participants | 40,203 | 1 | 6/60 | 4,020 |
| Personal Information Update | Participants | 40,203 | 1 | 3/60 | 2,010 |
| Initial Notification of Death | Next of Kin | 900 | 1 | 5/60 | 75 |
| Initial Notification of Death | Physician/Office Staff | 15 | 1 | 5/60 | 1 |
| Total | 41,118 | 121,524 | 10,796 |
Dated: June 9, 2016.
Valery Gheen,
NHLBI Project Clearance Liaison, National Institutes of Health.
[FR Doc. 2016-14057 Filed 6-14-16; 8:45 am]
BILLING CODE 4140-01-P