Human Tissue Intended for Transplantation

Forms and Documents

Document Name	Status
0302 Section 264.txt Supplementary Document	0000-00-00
0302 21cfr1270 35.pdf Supplementary Document	0000-00-00
0302 21cfr1270 33.pdf Supplementary Document	0000-00-00
0302 21cfr1270 31.pdf Supplementary Document	0000-00-00
0302 ss 3-6-2007.doc Supporting Statement A	0000-00-00

IC Document Collections

IC ID	Document Title	Status
5867	Human Tissue Intended for Transplantation	Modified
179893	Human Tissue Intended for Transplantation	New
179892	Human Tissue Intended for Transplantation	New
179891	Human Tissue Intended for Transplantation	New
179890	Human Tissue Intended for Transplantation	New
179889	Human Tissue Intended for Transplantation	New

ICR Details

OMB Control No: 0910-0302	ICR Reference No: 200704-0910-003
Status: Historical Active	Previous ICR Reference No: 200401-0910-011
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Human Tissue Intended for Transplantation
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 with change	Conclusion Date: 08/20/2007
	Date Received in OIRA: 04/27/2007
Terms of Clearance: This information collection request is approved as revised. Note that the burden tables were changed to reflect that the burden changes were due to adjustment rather than agency action, consistent with submission as "extension without change."

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2010	36 Months From Approved	08/31/2007
Responses	782,562	0	62
Time Burden (Hours)	783,332	0	592,166
Cost Burden (Dollars)	0	0	0

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Abstract: This collection of information requirements helps prevent the transmission of communicable diseases through transplantation by allowing FDA inspections of persons and tissue establishments engaged in the recovery, screening, testing, processing, storage, or distribution of human tissue. These facilities are required to meet standards intended to ensure appropriate screening and testing of human tissue donors and insure that records are kept documenting that the appropriate screening and testing have been completed. If regulations are violated, then retention, recall and destruction orders may be issued to these facilities. Respondents to this collection of information are manufacturers of human tissue intended for transplantation.

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Authorizing Statute(s): US Code: 42 USC 264 Name of Law: Public Health Service Act
  

Citations for New Statutory Requirements: None

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

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	71 FR 70410	12/04/2006
30-day Notice:	Federal Register Citation:	Citation Date:
	72 FR 20555	04/25/2007
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 6

IC Title	Form No.	Form Name
Human Tissue Intended for Transplantation
Human Tissue Intended for Transplantation
Human Tissue Intended for Transplantation
Human Tissue Intended for Transplantation
Human Tissue Intended for Transplantation
Human Tissue Intended for Transplantation

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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	782,562	62	0	0	782,500	0
Annual Time Burden (Hours)	783,332	592,166	0	0	191,166	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: The increase in burden is due to the increase in the number of conventional tissue products. The number doubled since our last request for approval.

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Annual Cost to Federal Government: $190,000

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)? Uncollected

Is this ICR related to the Pandemic Response? Uncollected

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Common Form ICR:  No

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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: 04/27/2007

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