Billing Code 4140-01-P
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-day comment request
The Clinical Trials Reporting Program (CTRP) Database (NCI)
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 recommendations for the proposed information
collection should be sent within 30 days of publication of this notice to
www.reginfo.gov/public/do/PRAMain. Find this particular information collection by
selecting "Currently under 30-day Review - Open for Public Comments" or by using the
search function.
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 E-mail 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 29, 2022, page 38765 (Vol. 87, No.
124) and allowed 60 days for public comment. One public comment was 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 10/31/2022 – EXTENSION, 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 data, and reduce redundant submissions. Clinical research administrators
submit information as designees of clinical investigators who conduct NCI-supported
clinical research. The designees can electronically access the CTRP Web site to complete
the initial trial registration. After registration, four amendments and four study subject
accrual updates occur per trial annually.
OMB approval is requested for three 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

3,000

Amendment

1,500

1

6,000

Update

1,500

1

6,000

Accrual Updates

3,000

15/60

3,000

Totals

9,000

27,000

Dated: September 13, 2022.
Diane Kreinbrink,
Project Clearance Liaison,
National Cancer Institute,
National Institutes of Health.
[FR Doc. 2022-20083 Filed: 9/15/2022 8:45 am; Publication Date: 9/16/2022]

18,000