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

Forms and Documents

Document Name	Status
Form 3356 SOP Update Form and Instruction	Removed
Form 3356 New SOPs Form and Instruction	Removed
Form 3356 1271.350(a)(1) & (a)(3) - Reporting Form and Instruction	Removed
Form 3356 1271.155(a) - Exemptions and Alternatives Form and Instruction	Removed
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
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
0543 SS for 2017 Extension.pdf Supporting Statement A	2017-03-29

IC Document Collections

IC ID	Document Title	Status
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
	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

---

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.

---

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:
	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

---

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

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

---

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:

---

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

---

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: 03/31/2017

---