AGENCY:
National Institutes of Health, HHS.
ACTION:
Notice.
SUMMARY:
In compliance with 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.
DATES:
Comments regarding this information collection are best assured of having their full effect if received within 30 days of the date of this publication.
ADDRESSES:
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.
FOR FURTHER INFORMATION CONTACT:
To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact: Gisele Sarosy, MD, Coordinating Center for Clinical Trials (CCCT), National Cancer Institute, 9609 Medical Center Drive, 6W134, Rockville, MD 20852 or call non-toll-free number 240-276-6172 or Email your request, including your address to: gisele.sarosy@nih.gov.
SUPPLEMENTARY INFORMATION:
This proposed information collection was previously published in the Federal Register on June 3, 2019, page 25550 (Vol. 84, No. 106 FR 25550) 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 Cancer Institute (NCI), 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.
In compliance with 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.
Proposed Collection: The Clinical Trials Reporting Program (CTRP) Database (NCI), 0925-0600, Expiration Date 08/31/2019—REVISION, National Cancer Institute (NCI), National Institutes of Health (NIH).
Need and Use of Information Collection: The Clinical Trials Reporting Program (CTRP) is an electronic resource that serves as a single, definitive source of information about all NCI-supported clinical research. This resource allows the NCI to consolidate reporting, aggregate information and reduce redundant submissions. Information is submitted by clinical research administrators as designees of clinical investigators who conduct NCI-supported clinical research. The designees can electronically access the CTRP website to complete the initial trial registration. Subsequent to registration, four amendments and four study subject accrual updates occur per trial annually.
OMB approval is requested for 3 years. There are no costs to respondents other than their time. The estimated annualized burden hours are 18,000.
Estimated Annualized Burden Hours
| Form name | Type of respondents | Number of respondents | Number of responses per respondent | Average time per response (in hours) | Total annual burden hours |
|---|---|---|---|---|---|
| Initial Registration | Clinical Trials | 3,000 | 1 | 1 | 3,000 |
| Amendment | 1,500 | 4 | 1 | 6,000 | |
| Update | 1,500 | 4 | 1 | 6,000 | |
| Accrual Updates | 3,000 | 4 | 15/60 | 3,000 | |
| Total | 27,000 | 18,000 |
Diane Kreinbrink,
Project Clearance Liaison, National Cancer Institute, National Institutes of Health.
[FR Doc. 2019-18202 Filed 8-22-19; 8:45 am]
BILLING CODE 4140-01-P