The Clinical Trials Reporting Program (CTRP) Database (NCI)

Forms and Documents

Document Name	Status
Form 2 Amendment for the Clinical Trials Reporting Program (CTRP) Database (NCI) Form	New
Form 1 Registration for the Clinical Trials Reporting Program (CTRP) Database (NCI) Form	New
NCI_CTRPDbase_Attachment 5.doc Supplementary Document	2009-06-30
NCI_CTRP_Attachment 4B_Research Organizations_20090603.doc Supplementary Document	2009-06-08
NCI_CTRP_Attachment 4A_NCI Advisory Boards_20090603.doc Supplementary Document	2009-06-08
NCI_CTRP_Attachment 3A_CTRP_quick_start_guide.pdf Supplementary Document	2009-06-08
NCI_CTRP_Attachment 1_CTWG_report_June2005.pdf Supplementary Document	2009-06-08
NCI_CTRP_Attachment 3B_CTRP-registration-users-guide-v2 0.pdf Supplementary Document	2009-06-08
NCI_CTRP_Memo re Necessity for Implementation of ARRA.doc Supplementary Document	2009-06-08
NCI_CTRP_Cover Memo_20090604.doc Supplementary Document	2009-06-08
NCI_CTRP_Attachment 6_OHSR Clearance.pdf Supplementary Document	2009-06-11
NCI_CTRP_SSA_20090626_final[1] Supporting Statement A	2009-06-30

IC Document Collections

IC ID	Document Title	Status
189519	Amendment for the Clinical Trials Reporting Program (CTRP) Database (NCI) Form	New
189518	Registration for the Clinical Trials Reporting Program (CTRP) Database (NCI) Form	New

ICR Details

OMB Control No: 0925-0600	ICR Reference No: 200906-0925-003
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/NIH	Agency Tracking No:
Title: The Clinical Trials Reporting Program (CTRP) Database (NCI)
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Emergency	Approval Requested By: 07/01/2009
OIRA Conclusion Action: Approved with change	Conclusion Date: 07/01/2009
	Date Received in OIRA: 06/11/2009
Terms of Clearance: Approved consistent with revised documents uploaded on 6/30/2009.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2010	6 Months From Approved
Responses	27,500	0	0
Time Burden (Hours)	33,000	0	0
Cost Burden (Dollars)	0	0	0

---

Abstract: This is a request for OMB to emergency process and approve The Clinical Trials Reporting Program (CTRP) Database for 6 months. The National Cancer Institute (NCI) is developing an electronic resource to serve as a single, definitive source of information about all NCI-supported clinical research, thereby enabling the NCI to execute its mission to reduce the burden of cancer and to ensure an optimal return on the nation's investment in cancer clinical research. Deployment and extension of the CTRP Database is an infrastructure development project that will be enabled by public funds expended pursuant to the American Recovery and Reinvestment Act of 2009, P.L. 111-5 ("Recovery Act"). In addition, deployment of this resource will allow the NCI to consolidate reporting, aggregate information and reduce redundant submissions. Information will be submitted by clinical research administrators as designees of clinical investigators who conduct NCI-supported clinical research. Authorization for emergency processing pursuant to 5 CFR 1320.13 is requested so that the information collection can begin by July 1, 2009.

Emergency Justfication: The information collection needs to commence by July 1, 2009 so that NCI can conduct effective prototyping of the database in order to deploy it systematically on a production basis by October 1, 2009 within the timelines of the Recovery Act. Given the long term nature of this project, the NCI cannot reasonably comply with the normal clearance procedures because the 60-day/30-day notice and comment periods will interfere with the timely collection of information. As documented in the attached Supporting Statement A, NCI has taken all practicable steps to consult with interested agencies and members of the public in order to minimize the burden of the proposed collection of information.

---

Authorizing Statute(s): US Code: 42 USC 407 (285a-2(a)(2)(D)) Name of Law: Public Health Service Act
   US Code: 42 USC 410 (285a-2(a)(1)) Name of Law: Public Health Service Act
   US Code: 42 USC 410 (285a-4(b)) Name of Law: Public Health Service Act
  

Citations for New Statutory Requirements: None

---

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

---

Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? No

---

Number of Information Collection (IC) in this ICR: 2

IC Title	Form No.	Form Name
Registration for the Clinical Trials Reporting Program (CTRP) Database (NCI)	1	CTRP Registration Screenshots
Amendment for the Clinical Trials Reporting Program (CTRP) Database (NCI)	2	CTRP Amendments Screenshots

---

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	27,500	0	0	27,500	0	0
Annual Time Burden (Hours)	33,000	0	0	33,000	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: This is a new collection of information with emergency processing. Deployment and extension of the CTRP Database is an infrastructure development project to be conducted pursuant to the American Recovery and Reinvestment Act of 2009.

---

Annual Cost to Federal Government: $4,200,000

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? Yes

Is this ICR related to the Pandemic Response? Uncollected

---

Common Form ICR:  No

---

On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 06/11/2009

---