Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)

Forms and Documents

Document	Type	Status	Availability
Form FDA-3356 Establishment Registration and Listing; Form FDA 3356; Eligibility Determination for Donors; and Current Good Tissue Practice	Form	Modified	Repair queued
Form FDA-3356 Establishment Registration and Listing; Form FDA 3356; Eligibility Determination for Donors; and Current Good Tissue Practice	Form	New	Repair queued
Form FDA-3356 Establishment Registration and Listing; Form FDA 3356; Eligibility Determination for Donors; and Current Good Tissue Practice	Form	New	Repair queued
Form FDA-3356 Establishment Registration and Listing; Form FDA 3356; Eligibility Determination for Donors; and Current Good Tissue Practice	Form	New	Repair queued
Form FDA-3356 Establishment Registration and Listing; Form FDA 3356; Eligibility Determination for Donors; and Current Good Tissue Practice	Form	New	Available
Form FDA-3356 Establishment Registration and Listing; Form FDA 3356; Eligibility Determination for Donors; and Current Good Tissue Practice	Form	New	Repair queued
Form FDA-3356 Establishment Registration and Listing; Form FDA 3356; Eligibility Determination for Donors; and Current Good Tissue Practice	Form	New	Available
Form FDA-3356 Establishment Registration and Listing; Form FDA 3356; Eligibility Determination for Donors; and Current Good Tissue Practice	Form	New	Available
Form FDA-3356 Establishment Registration and Listing; Form FDA 3356; Eligibility Determination for Donors; and Current Good Tissue Practice	Form	New	Available
Form FDA-3356 Establishment Registration and Listing; Form FDA 3356; Eligibility Determination for Donors; and Current Good Tissue Practice	Form	New	Available
Form FDA-3356 Establishment Registration and Listing; Form FDA 3356; Eligibility Determination for Donors; and Current Good Tissue Practice	Form	New	Repair queued
Form FDA-3356 Establishment Registration and Listing; Form FDA 3356; Eligibility Determination for Donors; and Current Good Tissue Practice	Form	New	Available
Form FDA-3356 Establishment Registration and Listing; Form FDA 3356; Eligibility Determination for Donors; and Current Good Tissue Practice	Form	New	Repair queued
Form FDA-3356 Establishment Registration and Listing; Form FDA 3356; Eligibility Determination for Donors; and Current Good Tissue Practice	Form	New	Repair queued
Form FDA-3356 Establishment Registration and Listing; Form FDA 3356; Eligibility Determination for Donors; and Current Good Tissue Practice	Form	New	Available
Form FDA-3356 Establishment Registration and Listing; Form FDA 3356; Eligibility Determination for Donors; and Current Good Tissue Practice	Form	New	Repair queued
Form FDA-3356 Establishment Registration and Listing; Form FDA 3356; Eligibility Determination for Donors; and Current Good Tissue Practice	Form	New	Repair queued
Form FDA-3356 Establishment Registration and Listing; Form FDA 3356; Eligibility Determination for Donors; and Current Good Tissue Practice	Form	New	Available
Form FDA-3356 Establishment Registration and Listing; Form FDA 3356; Eligibility Determination for Donors; and Current Good Tissue Practice	Form	New	Available
Form FDA-3356 Establishment Registration and Listing; Form FDA 3356; Eligibility Determination for Donors; and Current Good Tissue Practice	Form	New	Available
Form FDA-3356 Establishment Registration and Listing; Form FDA 3356; Eligibility Determination for Donors; and Current Good Tissue Practice	Form	New	Repair queued
Form FDA-3356 Establishment Registration and Listing; Form FDA 3356; Eligibility Determination for Donors; and Current Good Tissue Practice	Form	New	Available
Form FDA-3356 Establishment Registration and Listing; Form FDA 3356; Eligibility Determination for Donors; and Current Good Tissue Practice	Form	New	Available
Form FDA-3356 Establishment Registration and Listing; Form FDA 3356; Eligibility Determination for Donors; and Current Good Tissue Practice	Form	New	Available
Form FDA-3356 Establishment Registration and Listing; Form FDA 3356; Eligibility Determination for Donors; and Current Good Tissue Practice	Form	New	Available
Form FDA-3356 Establishment Registration and Listing; Form FDA 3356; Eligibility Determination for Donors; and Current Good Tissue Practice	Form	New	Repair queued
Form FDA-3356 Establishment Registration and Listing; Form FDA 3356; Eligibility Determination for Donors; and Current Good Tissue Practice	Form	New	Available
0543 FDA-3356.pdf	Supplementary Document	Uploaded 2007-04-09	Available
0543 CoverMemotoOMB 4-9-07.doc	Supplementary Document	Uploaded 2007-04-09	Available
21cfr1271.370.pdf	Supplementary Document	Uploaded 2007-04-09	Available
21cfr1271.350.pdf	Supplementary Document	Uploaded 2007-04-09	Available
21cfr1271.320.pdf	Supplementary Document	Uploaded 2007-04-09	Available
21cfr1271.290.pdf	Supplementary Document	Uploaded 2007-04-09	Available
21cfr1271.270.pdf	Supplementary Document	Uploaded 2007-04-09	Available
21cfr1271.265.pdf	Supplementary Document	Uploaded 2007-04-09	Available
21cfr1271.260.pdf	Supplementary Document	Uploaded 2007-04-09	Available
21cfr1271.230.pdf	Supplementary Document	Uploaded 2007-04-09	Available
21cfr1271.210.pdf	Supplementary Document	Uploaded 2007-04-09	Available
21cfr1271.200.pdf	Supplementary Document	Uploaded 2007-04-09	Available
21cfr1271.195.pdf	Supplementary Document	Uploaded 2007-04-09	Available
21cfr1271.190.pdf	Supplementary Document	Uploaded 2007-04-09	Available
21cfr1271.160.pdf	Supplementary Document	Uploaded 2007-04-09	Available
21cfr1271.155.pdf	Supplementary Document	Uploaded 2007-04-09	Repair queued
21cfr1271.60.pdf	Supplementary Document	Uploaded 2007-04-09	Available
21cfr1271.50.pdf	Supplementary Document	Uploaded 2007-04-09	Available
21cfr1271.55.pdf	Supplementary Document	Uploaded 2007-04-09	Available
21cfr1271.65.pdf	Supplementary Document	Uploaded 2007-04-09	Available
21cfr1271.47.pdf	Supplementary Document	Uploaded 2007-04-09	Available
21cfr1271.26.pdf	Supplementary Document	Uploaded 2007-04-09	Available
21cfr1271.25.pdf	Supplementary Document	Uploaded 2007-04-09	Available
21cfr1271.21.pdf	Supplementary Document	Uploaded 2007-04-09	Available
21cfr1271.10.pdf	Supplementary Document	Uploaded 2007-04-09	Available
0543 ss 4-3-07.doc	Supporting Statement A	Uploaded 2007-04-09	Available

IC Document Collections

IC ID	Collection	Type	Status	Form
6263	Establishment Registration and Listing; Form FDA 3356; Eligibility Determination for Donors; and Current Good Tissue Practice	Form	Modified
179945	Establishment Registration and Listing; Form FDA 3356; Eligibility Determination for Donors; and Current Good Tissue Practice	Form	New
179944	Establishment Registration and Listing; Form FDA 3356; Eligibility Determination for Donors; and Current Good Tissue Practice	Form	New
179943	Establishment Registration and Listing; Form FDA 3356; Eligibility Determination for Donors; and Current Good Tissue Practice	Form	New
179942	Establishment Registration and Listing; Form FDA 3356; Eligibility Determination for Donors; and Current Good Tissue Practice	Form	New
179941	Establishment Registration and Listing; Form FDA 3356; Eligibility Determination for Donors; and Current Good Tissue Practice	Form	New
179940	Establishment Registration and Listing; Form FDA 3356; Eligibility Determination for Donors; and Current Good Tissue Practice	Form	New
179939	Establishment Registration and Listing; Form FDA 3356; Eligibility Determination for Donors; and Current Good Tissue Practice	Form	New
179938	Establishment Registration and Listing; Form FDA 3356; Eligibility Determination for Donors; and Current Good Tissue Practice	Form	New
179937	Establishment Registration and Listing; Form FDA 3356; Eligibility Determination for Donors; and Current Good Tissue Practice	Form	New
179936	Establishment Registration and Listing; Form FDA 3356; Eligibility Determination for Donors; and Current Good Tissue Practice	Form	New
179935	Establishment Registration and Listing; Form FDA 3356; Eligibility Determination for Donors; and Current Good Tissue Practice	Form	New
179934	Establishment Registration and Listing; Form FDA 3356; Eligibility Determination for Donors; and Current Good Tissue Practice	Form	New
179933	Establishment Registration and Listing; Form FDA 3356; Eligibility Determination for Donors; and Current Good Tissue Practice	Form	New
179932	Establishment Registration and Listing; Form FDA 3356; Eligibility Determination for Donors; and Current Good Tissue Practice	Form	New
179931	Establishment Registration and Listing; Form FDA 3356; Eligibility Determination for Donors; and Current Good Tissue Practice	Form	New
179930	Establishment Registration and Listing; Form FDA 3356; Eligibility Determination for Donors; and Current Good Tissue Practice	Form	New
179929	Establishment Registration and Listing; Form FDA 3356; Eligibility Determination for Donors; and Current Good Tissue Practice	Form	New
179928	Establishment Registration and Listing; Form FDA 3356; Eligibility Determination for Donors; and Current Good Tissue Practice	Form	New
179927	Establishment Registration and Listing; Form FDA 3356; Eligibility Determination for Donors; and Current Good Tissue Practice	Form	New
179926	Establishment Registration and Listing; Form FDA 3356; Eligibility Determination for Donors; and Current Good Tissue Practice	Form	New
179925	Establishment Registration and Listing; Form FDA 3356; Eligibility Determination for Donors; and Current Good Tissue Practice	Form	New
179924	Establishment Registration and Listing; Form FDA 3356; Eligibility Determination for Donors; and Current Good Tissue Practice	Form	New
179923	Establishment Registration and Listing; Form FDA 3356; Eligibility Determination for Donors; and Current Good Tissue Practice	Form	New
179922	Establishment Registration and Listing; Form FDA 3356; Eligibility Determination for Donors; and Current Good Tissue Practice	Form	New
179921	Establishment Registration and Listing; Form FDA 3356; Eligibility Determination for Donors; and Current Good Tissue Practice	Form	New
179920	Establishment Registration and Listing; Form FDA 3356; Eligibility Determination for Donors; and Current Good Tissue Practice	Form	New

ICR Details

OMB Control No: 0910-0543	ICR Reference No: 200705-0910-001
Status: Historical Active	Previous ICR Reference No: 200404-0910-004
Agency/Subagency: HHS/FDA	Agency Tracking No:
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 with change	Conclusion Date: 08/17/2007
	Date Received in OIRA: 05/01/2007
Terms of Clearance: Please note burden table amended to reflect agency adjustment rather than program changes.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2010	36 Months From Approved	08/31/2007
Responses	5,848,435	0	1,274,272
Time Burden (Hours)	3,086,115	0	866,240
Cost Burden (Dollars)	0	0	0

---

Abstract: Under section 361 of the Public Health Service Act (the PHS Act) (42 U.S.C. 264), FDA may issue and enforce regulations necessary to prevent the introduction, transmission, or spread of communicable diseases between the States or possessions or from foreign countries into the States. As derivatives of the human body, all HCT/Ps pose some risk of carrying pathogens that could potentially infect recipients or handlers. FDA has issued regulations related to HCT/Ps involving establishment registration and listing using Form FDA 3356; eligibility determination for donors; and current good tissue practice (CGTP). Form FDA 3356: Establishment Registration and Listing for Human Cells, Tissues, and Cellular and Tissue-Based Products is used to submit the required information (???? 1271.10, 1271.21, 1271.25, and 1271.26).

---

Authorizing Statute(s): US Code: 42 USC 264 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
60-day Notice:	Federal Register Citation:	Citation Date:
	72 FR 3858	01/26/2007
30-day Notice:	Federal Register Citation:	Citation Date:
	72 FR 21027	04/27/2007
Did the Agency receive public comments on this ICR? No

---

Number of Information Collection (IC) in this ICR: 27

IC Title	Form No.	Form Name
Establishment Registration and Listing; Form FDA 3356; Eligibility Determination for Donors; and Current Good Tissue Practice	FDA-3356, FDA-3356	FDA-3356 ,   FDA-3356
Establishment Registration and Listing; Form FDA 3356; Eligibility Determination for Donors; and Current Good Tissue Practice	FDA-3356, FDA-3356	FDA-3356 ,   FDA-3356
Establishment Registration and Listing; Form FDA 3356; Eligibility Determination for Donors; and Current Good Tissue Practice	FDA-3356, FDA-3356	FDA-3356 ,   FDA-3356
Establishment Registration and Listing; Form FDA 3356; Eligibility Determination for Donors; and Current Good Tissue Practice	FDA-3356, FDA-3356	FDA-3356 ,   FDA-3356
Establishment Registration and Listing; Form FDA 3356; Eligibility Determination for Donors; and Current Good Tissue Practice	FDA-3356, FDA-3356	FDA-3356 ,   FDA-3356
Establishment Registration and Listing; Form FDA 3356; Eligibility Determination for Donors; and Current Good Tissue Practice	FDA-3356, FDA-3356	FDA-3356 ,   FDA-3356
Establishment Registration and Listing; Form FDA 3356; Eligibility Determination for Donors; and Current Good Tissue Practice	FDA-3356, FDA-3356	FDA-3356 ,   FDA-3356
Establishment Registration and Listing; Form FDA 3356; Eligibility Determination for Donors; and Current Good Tissue Practice	FDA-3356, FDA-3356	FDA-3356 ,   FDA-3356
Establishment Registration and Listing; Form FDA 3356; Eligibility Determination for Donors; and Current Good Tissue Practice	FDA-3356, FDA-3356	FDA-3356 ,   FDA-3356
Establishment Registration and Listing; Form FDA 3356; Eligibility Determination for Donors; and Current Good Tissue Practice	FDA-3356, FDA-3356	FDA-3356 ,   FDA-3356
Establishment Registration and Listing; Form FDA 3356; Eligibility Determination for Donors; and Current Good Tissue Practice	FDA-3356, FDA-3356	FDA-3356 ,   FDA-3356
Establishment Registration and Listing; Form FDA 3356; Eligibility Determination for Donors; and Current Good Tissue Practice	FDA-3356, FDA-3356	FDA-3356 ,   FDA-3356
Establishment Registration and Listing; Form FDA 3356; Eligibility Determination for Donors; and Current Good Tissue Practice	FDA-3356, FDA-3356	FDA-3356 ,   FDA-3356
Establishment Registration and Listing; Form FDA 3356; Eligibility Determination for Donors; and Current Good Tissue Practice	FDA-3356, FDA-3356	FDA-3356 ,   FDA-3356
Establishment Registration and Listing; Form FDA 3356; Eligibility Determination for Donors; and Current Good Tissue Practice	FDA-3356, FDA-3356	FDA-3356 ,   FDA-3356
Establishment Registration and Listing; Form FDA 3356; Eligibility Determination for Donors; and Current Good Tissue Practice	FDA-3356, FDA-3356	FDA-3356 ,   FDA-3356
Establishment Registration and Listing; Form FDA 3356; Eligibility Determination for Donors; and Current Good Tissue Practice	FDA-3356, FDA-3356	FDA-3356 ,   FDA-3356
Establishment Registration and Listing; Form FDA 3356; Eligibility Determination for Donors; and Current Good Tissue Practice	FDA-3356, FDA-3356	FDA-3356 ,   FDA-3356
Establishment Registration and Listing; Form FDA 3356; Eligibility Determination for Donors; and Current Good Tissue Practice	FDA-3356, FDA-3356	FDA-3356 ,   FDA-3356
Establishment Registration and Listing; Form FDA 3356; Eligibility Determination for Donors; and Current Good Tissue Practice	FDA-3356, FDA-3356	FDA-3356 ,   FDA-3356
Establishment Registration and Listing; Form FDA 3356; Eligibility Determination for Donors; and Current Good Tissue Practice	FDA-3356, FDA-3356	FDA-3356 ,   FDA-3356
Establishment Registration and Listing; Form FDA 3356; Eligibility Determination for Donors; and Current Good Tissue Practice	FDA-3356, FDA-3356	FDA-3356 ,   FDA-3356
Establishment Registration and Listing; Form FDA 3356; Eligibility Determination for Donors; and Current Good Tissue Practice	FDA-3356, FDA-3356	FDA-3356 ,   FDA-3356
Establishment Registration and Listing; Form FDA 3356; Eligibility Determination for Donors; and Current Good Tissue Practice	FDA-3356, FDA-3356	FDA-3356 ,   FDA-3356
Establishment Registration and Listing; Form FDA 3356; Eligibility Determination for Donors; and Current Good Tissue Practice	FDA-3356, FDA-3356	FDA-3356 ,   FDA-3356
Establishment Registration and Listing; Form FDA 3356; Eligibility Determination for Donors; and Current Good Tissue Practice	FDA-3356, FDA-3356	FDA-3356 ,   FDA-3356
Establishment Registration and Listing; Form FDA 3356; Eligibility Determination for Donors; and Current Good Tissue Practice	FDA-3356, FDA-3356	FDA-3356 ,   FDA-3356

---

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	5,848,435	1,274,272	0	0	4,574,163	0
Annual Time Burden (Hours)	3,086,115	866,240	0	0	2,219,875	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 2004 burden estimate for 0910-0543 was 866,240. The increase in burden to 3,086,113.65 is attributed to the consolidation of OMB packages: 0910-0469 and 0910-0559 and an increase in the number of establishments as well as total annual responses and records based on updated information since the issuance of the Eligibility Determination for Donors of HCT/Ps and CGTP final rules.

---

Annual Cost to Federal Government: $3,378,622

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: 05/01/2007

---