Information Program on Clinical Trials for Serious and Life-Threatening Diseases: Maintaining a Databank

Forms and Documents

Document Name	Status
0459 Data Element Definitions.doc Supplementary Document	2007-10-10
0459 FDAMA 113.doc Supplementary Document	2007-10-10
0910-0459 FDA-CMS revisions-1-2-08.doc Supporting Statement A	2008-01-08

IC Document Collections

IC ID	Document Title	Status
6153	Information Program on Clinical Trials for Serious and Life-Threatening Diseases: Maintaining a Databank Other-Guidance document	Modified
182781	Information Program on Clinical Trials for Serious and Life-Threatening Diseases: Maintaining a Databank Other-Data Element Definitions (CMS)	New
182780	Information Program on Clinical Trials for Serious and Life-Threatening Diseases: Maintaining a Databank Other-Guidance document	New
182779	Information Program on Clinical Trials for Serious and Life-Threatening Diseases: Maintaining a Databank Other-Guidance document	New
182778	Information Program on Clinical Trials for Serious and Life-Threatening Diseases: Maintaining a Databank Other-Guidance document	New

ICR Details

OMB Control No: 0910-0459	ICR Reference No: 200711-0910-004
Status: Historical Active	Previous ICR Reference No: 200402-0910-005
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Information Program on Clinical Trials for Serious and Life-Threatening Diseases: Maintaining a Databank
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 01/10/2008
	Date Received in OIRA: 11/19/2007
Terms of Clearance: Approved as amended by FDA in its revised supporting statement with appropriate changes to the burden accounting.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2011	36 Months From Approved	01/31/2008
Responses	43,499	0	38,514
Time Burden (Hours)	200,839	0	177,165
Cost Burden (Dollars)	0	0	0

---

Abstract: Sponsors of Investigational New Drug Applications are required, under the Food and Drug Administration Modernization Act, to submit information about clinical trials for serious or life-threatening diseases to a publicly-accessible clinical trials data bank developed by the National Library of Medicine.

---

Authorizing Statute(s): US Code: 42 USC 1395y Name of Law: Exclusions from Coverage and Medicare as Secondary Payer
   PL: Pub.L. 105 - 115 113 Name of Law: FDAMA
  

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
60-day Notice:	Federal Register Citation:	Citation Date:
	72 FR 27140	05/14/2007
30-day Notice:	Federal Register Citation:	Citation Date:
	72 FR 59295	10/19/2007
Did the Agency receive public comments on this ICR? No

---

Number of Information Collection (IC) in this ICR: 5

IC Title	Form No.	Form Name
Information Program on Clinical Trials for Serious and Life-Threatening Diseases: Maintaining a Databank
Information Program on Clinical Trials for Serious and Life-Threatening Diseases: Maintaining a Databank
Information Program on Clinical Trials for Serious and Life-Threatening Diseases: Maintaining a Databank
Information Program on Clinical Trials for Serious and Life-Threatening Diseases: Maintaining a Databank
Information Program on Clinical Trials for Serious and Life-Threatening Diseases: Maintaining a Databank

---

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	43,499	38,514	0	745	4,240	0
Annual Time Burden (Hours)	200,839	177,165	0	4,172	19,502	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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: We believe the previous burden estimate of 177,165 hours per year underestimated the burden. The new estimate of 196,668 hours per year more accurately reflects the burden. The addition of CMS's estimated burden hours has increased the total.

---

Annual Cost to Federal Government: $0

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)? Uncollected

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: 11/19/2007

---