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

Forms and Documents

Document	Type	Status	Availability
Form 3356 SOP Update	Form and Instruction	Removed	Available
Form 3356 New SOPs	Form and Instruction	Removed	Repair queued
Form 3356 1271.350(a)(1) & (a)(3) - Reporting	Form and Instruction	Removed	Available
Form 3356 1271.155(a) - Exemptions and Alternatives	Form and Instruction	Removed	Available
Form 3356 1271.10(b)(2), 1271.21(c)(ii) and 1271.25(c) - Are my HCT/Ps regulated solely under Section 361 of the PHS Act?/When do I register?/What info. is required for registration?	Form and Instruction	Removed	Available
Form 3356 1271.10(b)(1) & (b)(2), 1271.21(a), and 1271.25(a)&(b) - Are my HCT/Ps regulated solely under section 361 of the PHS Act?/When do I register?/What info. is required for registration?	Form and Instruction	Removed	Available
0543 SS for 2017 Extension.pdf	Supporting Statement A	Uploaded 2017-03-29	Available

IC Document Collections

IC ID	Collection	Type	Status	Form
6263	Human Cells, Tissues, and Cellular- and Tissue-Based Products (HCT/P's)		Modified
210192	Third Party Disclosures for HCT/P's		Modified
210191	1271.290(f) - Tracking		Removed
210190	1271.290(c) - Tracking		Removed
210189	1271.60(c) and (d)(2) - What quarantine and other requirements apply before the donor-eligibility determination is complete?		Removed
210188	1271.55(a) - What records must accompany an HCT/P after the donor-eligibility determination is complete?		Removed
210187	1271.320(b) - Complaint File		Removed
210186	1271.290(d) and (e) - Tracking		Removed
210185	1271.270(e) - Records		Removed
210184	1271.270(a) - Records		Removed
210183	1271.265(e) - Receipt, predistribution shipment, and distribution of an HCT/P		Removed
210182	1271.265(c)(3) - Receipt, predistribution0 shipment, and distribution of an HCT/P		Removed
210181	1271.265(c)(1) - Receipt, predistribution shipment, and distribution of an HCT/P		Removed
210180	1271.260(e) - Storage		Removed
210179	1271.260(d) - Storage		Removed
210178	1271.230(c) - Process validation		Removed
210177	1271.230(a) - Process Validation		Removed
210176	1271.210(d) - Supplies and Reagents		Removed
210175	1271.200(e) - Equipment		Removed
210174	1271.195(d) - Environmental control and monitoring		Removed
210173	1271.190(d)(2) - Facilities		Removed
210172	1271.160(d) - Establishment and maintenance of a quality program		Removed
210171	1271.160(b)(3) and (b)(6) - Establishment and maintenance of a quality program		Removed
210170	1271.155(f) - Exemptions and Alternatives		Removed
210169	1271.60(d)(3) & (d)(4), 1271.65(b)(3) - What quarantine & other requirements apply?/How do I store an HCT/P from a donor determined to be ineligible?		Removed
210168	1271.50(a) - How do I determine a donor is eligible?		Removed
210167	1271.47(d) - What procedures must I establish and maintain?		Removed
210166	SOP Update	Form and Instruction	Removed
210165	New SOPs	Form and Instruction	Removed
210164	1271.350(a)(1) & (a)(3) - Reporting	Form and Instruction	Removed
210163	1271.155(a) - Exemptions and Alternatives	Form and Instruction	Removed
210162	1271.26 - When must I amend my establishment registration?		Removed
210161	1271.10(b)(2), 1271.21(c)(ii) and 1271.25(c) - Are my HCT/Ps regulated solely under Section 361 of the PHS Act?/When do I register?/What info. is required for registration?	Form and Instruction	Removed
210160	1271.10(b)(1) & (b)(2), 1271.21(a), and 1271.25(a)&(b) - Are my HCT/Ps regulated solely under section 361 of the PHS Act?/When do I register?/What info. is required for registration?	Form and Instruction	Removed
179932	1271.55(d)(4) - What records must accompany an HCT/P?		Removed
179931	1271.55(d)(2) - What records must accompany an HCT/Ps?		Removed
179930	1271.55(d)(1) - What records must accompany an HCT/Ps?		Removed

ICR Details

OMB Control No: 0910-0543	ICR Reference No: 201703-0910-007
Status: Historical Active	Previous ICR Reference No: 201401-0910-008
Agency/Subagency: HHS/FDA	Agency Tracking No: CBER
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: 06/27/2017
Retrieve Notice of Action (NOA)	Date Received in OIRA: 03/31/2017
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2020	36 Months From Approved	06/30/2017
Responses	14,181,815	0	13,672,276
Time Burden (Hours)	9,336,048	0	3,938,614
Cost Burden (Dollars)	0	0	0

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Abstract: The information collection supports agency regulations regarding eligibility determination for donors of human cells, tissues, and cellular and tissue-based products (HCT/Ps). Respondents to the collection are manufacturers of these products subject to public health protection provisions under the Federal Food, Drug, and Cosmetic Act.

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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:
	81 FR 60170	08/31/2016
30-day Notice:	Federal Register Citation:	Citation Date:
	82 FR 16040	03/31/2017
Did the Agency receive public comments on this ICR? No

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

IC Title	Form No.	Form Name
1271.10(b)(1) & (b)(2), 1271.21(a), and 1271.25(a)&(b) - Are my HCT/Ps regulated solely under section 361 of the PHS Act?/When do I register?/What info. is required for registration?	3356	Establishment Registration and Listing for HCT/Ps
1271.10(b)(2), 1271.21(c)(ii) and 1271.25(c) - Are my HCT/Ps regulated solely under Section 361 of the PHS Act?/When do I register?/What info. is required for registration?	3356	Establishment Registration and Listing for HCT/Ps
1271.155(a) - Exemptions and Alternatives	3356	Establishment Registration and Listing for HCT/Ps
1271.155(f) - Exemptions and Alternatives
1271.160(b)(3) and (b)(6) - Establishment and maintenance of a quality program
1271.160(d) - Establishment and maintenance of a quality program
1271.190(d)(2) - Facilities
1271.195(d) - Environmental control and monitoring
1271.200(e) - Equipment
1271.210(d) - Supplies and Reagents
1271.230(a) - Process Validation
1271.230(c) - Process validation
1271.26 - When must I amend my establishment registration?
1271.260(d) - Storage
1271.260(e) - Storage
1271.265(c)(1) - Receipt, predistribution shipment, and distribution of an HCT/P
1271.265(c)(3) - Receipt, predistribution0 shipment, and distribution of an HCT/P
1271.265(e) - Receipt, predistribution shipment, and distribution of an HCT/P
1271.270(a) - Records
1271.270(e) - Records
1271.290(c) - Tracking
1271.290(d) and (e) - Tracking
1271.290(f) - Tracking
1271.320(b) - Complaint File
1271.350(a)(1) & (a)(3) - Reporting	3356	Establishment List and Registration for HCT/Ps
1271.47(d) - What procedures must I establish and maintain?
1271.50(a) - How do I determine a donor is eligible?
1271.55(a) - What records must accompany an HCT/P after the donor-eligibility determination is complete?
1271.55(d)(1) - What records must accompany an HCT/Ps?
1271.55(d)(2) - What records must accompany an HCT/Ps?
1271.55(d)(4) - What records must accompany an HCT/P?
1271.60(c) and (d)(2) - What quarantine and other requirements apply before the donor-eligibility determination is complete?
1271.60(d)(3) & (d)(4), 1271.65(b)(3) - What quarantine & other requirements apply?/How do I store an HCT/P from a donor determined to be ineligible?
Human Cells, Tissues, and Cellular- and Tissue-Based Products (HCT/P's)
New SOPs	3356	Establishment Regirstation and Listing for HCT/Ps
SOP Update	3356	Establishment Registration and Listing for HCT/Ps
Third Party Disclosures for HCT/P's

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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	14,181,815	13,672,276	0	0	509,539	0
Annual Time Burden (Hours)	9,336,048	3,938,614	0	0	5,397,434	0
Annual Cost Burden (Dollars)	0	0	0	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:

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Annual Cost to Federal Government: $3,906,619

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]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

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: 03/31/2017

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