Human Tissue Intended for Transplantation

Forms and Documents

Document Name	Status
0302 Human tissue transplantation SSA 2020 EXT.pdf Supporting Statement A	2020-01-23

IC Document Collections

IC ID	Document Title	Status
5867	Human Tissue Intended for Transplantation	Modified
179893	Specific Records -- 1270.35(d)	Removed
179892	Specific Records -- 1270.35(c)	Removed
179891	Records, General Requirements -- 1270.33(a), (f), and (h), and 1270.35(a) and (b)	Removed
179890	Written Procedures -- 1270.31(a) and (b)	Removed

ICR Details

OMB Control No: 0910-0302	ICR Reference No: 202001-0910-004
Status: Active	Previous ICR Reference No: 201701-0910-011
Agency/Subagency: HHS/FDA	Agency Tracking No: CBER
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 without change	Conclusion Date: 02/18/2020
	Date Received in OIRA: 01/24/2020
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/2023	36 Months From Approved	03/31/2020
Responses	625,999	0	625,999
Time Burden (Hours)	626,735	0	626,735
Cost Burden (Dollars)	28,203,075	0	0

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Abstract: The information collection requirements help prevent the transmission of communicable diseases through human tissue transplantation by requiring that written SOPs be prepared and followed for the following: (1) infectious disease testing; (2) determining the medical history of the donor; (3) designating and identifying quarantined tissue; and (4) preventing infectious disease contamination or cross-contamination of tissue during processing. The regulations require maintenance of records of all significant steps in the infectious disease testing, and screening, and require that these records be made available for FDA inspection. Adequate donor screening and testing must be recorded so that the suitability of the tissue can be determined. If FDA is unable to ascertain how a tissue donor was screened or tested, or if the tissue was distributed in violation of the regulations, then recall, retention, and/or destruction orders may be issued by FDA in accordance with codified administrative procedures.

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Authorizing Statute(s): US Code: 42 USC 264 Name of Law: Public Health Service Act; Regulations to control communicable diseases
  

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:
	84 FR 50039	09/24/2019
30-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 1167	01/09/2020
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Human Tissue Intended for Transplantation
Written Procedures -- 1270.31(a) and (b)
Records, General Requirements -- 1270.33(a), (f), and (h), and 1270.35(a) and (b)
Specific Records -- 1270.35(c)
Specific Records -- 1270.35(d)

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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	625,999	625,999	0	0	0	0
Annual Time Burden (Hours)	626,735	626,735	0	0	0	0
Annual Cost Burden (Dollars)	28,203,075	0	0	0	28,203,075	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: There is no adjustment to the burden hours from the previous estimate, however, we have uploaded cost information to appear at omb.report.

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Annual Cost to Federal Government: $595,200

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     Yes

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     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: 01/24/2020

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