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View ICR - OIRA Conclusion

OMB Control No: 0910-0543	ICR Reference No: 201401-0910-008
Status: Historical Active	Previous ICR Reference No: 201008-0910-004
Agency/Subagency: HHS/FDA	Agency Tracking No: 21316
Title: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 03/12/2014
Retrieve Notice of Action (NOA)	Date Received in OIRA: 01/28/2014
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2017	36 Months From Approved	03/31/2014
Responses	13,672,276	0	9,174,735
Time Burden (Hours)	3,938,614	0	3,923,214
Cost Burden (Dollars)	0	0	0

Abstract: The information FDA receives from establishments complying with registration and listing requirements is necessary to regulate the industries involved with the recovery, screening, testing, processing, storage, and distribution of HCT/Ps. The information allows FDA to efficiently and effectively handle emerging public health concerns related to HCT/Ps. The information also aids FDA to monitor the industry, to distribute educational materials, and to inform the industry about FDA requirements, guidances, and policies, and to identify entities that may be subject to FDA regulation. Documentation of donor eligibility determination provides to the user that all of the donor's medical history and social behavior were reviewed for high risk for or clinical evidence of communicable diseases, and that all of the required testing was completed. Each distributed HCT/P must have the certain accompanying documentation, e.g., a summary of the records used to determine eligibility. Other reporting and recordkeeping requirements in 21 CFR Part 1271 are designed to fully disclose the screening and testing results to the user when using products from donors who are determined to be ineligible or whose eligibility has not yet been determined in an urgent medical need. HCT/P establishments are required to maintain records for a minimum of 10 years. Certain HCT/Ps have long storage periods and advances in medical diagnosis and therapy also have created opportunities for disease prevention or treatment many years after a recipient's exposure to a donor later determined to be at risk for communicable disease agents or diseases. The CGTP information collection provisions provide, e.g., additional measures for preventing the introduction, transmission, or spread of communicable disease.

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	13,672,276	9,174,735	4,497,541
Annual Time Burden (Hours)	3,938,614	3,923,214	15,400
Annual Cost Burden (Dollars)	0	0	0

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

Burden Increase Due to:

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

Burden Reduction Due to:

Short Statement: The previous burden estimate in 2011 was 3,871,713 hours. The slight overall increase in burden to 3,928,592 hours (66,879 hours) is mostly attirubted to an inrease in the number of establishments and corresponding records under Sections 1271.47, 1271.50, 1271.55, 1271.270, and 1271.320 in the recordkeeping burden chart. A third-party disclosure chart was added for followng regulations previously included under the reporting burden chart: Sections 1271.55, 1271.60, 1271.290, and 1271.370. Therefore, there was a decrese under the reporting chart from 1,905,773 hours in 2011 to 4,018 (-1,901,755) hours; and a correspondeing new increase of 1,903,336 hours under the disclosure chart.