Human Cells, Tissues, and Cellular and Tissue-Based Products

Forms and Documents

Document Name	Status
0543 Supporting Statement 2023 7-11-23.docx Supporting Statement A	2023-07-12

IC Document Collections

IC ID	Document Title	Status
6263	Reporting and recordkeeping requirements for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Other-eHCTERS Screenshot	Modified
210192	Third Party Disclosures for HCT/Ps	Modified

ICR Details

OMB Control No: 0910-0543	ICR Reference No: 202301-0910-011
Status: Received in OIRA	Previous ICR Reference No: 202004-0910-007
Agency/Subagency: HHS/FDA	Agency Tracking No: CBER
Title: Human Cells, Tissues, and Cellular and Tissue-Based Products
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 07/13/2023

	Requested	Previously Approved
Expiration Date	36 Months From Approved	07/31/2023
Responses	16,418,257	16,766,100
Time Burden (Hours)	4,626,333	4,776,470
Cost Burden (Dollars)	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:
	88 FR 24193	04/19/2023
30-day Notice:	Federal Register Citation:	Citation Date:
	88 FR 43567	07/10/2023
Did the Agency receive public comments on this ICR? Yes

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

IC Title	Form No.	Form Name
Reporting and recordkeeping requirements for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
Third Party Disclosures for HCT/Ps

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ICR Summary of Burden

	Total Request	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	16,418,257	16,766,100	0	0	-347,843	0
Annual Time Burden (Hours)	4,626,333	4,776,470	0	0	-150,137	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: Our estimated burden for the information collection reflects an overall reduction of 150,137 hours and 347,843 responses annually, which corresponds to a decrease in the number HCT/P establishments and a decrease in the number HCT/Ps distributed since our last evaluation.

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Annual Cost to Federal Government: $4,406,247

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? No

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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: 07/13/2023

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