Current Good Manufacturing Practices for Blood and Related Regulations for and Blood Components; and Requirements for Donor Testing, Donor Notification, and "Lookback"

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability

No forms / supporting documents in this ICR. Check IC Document Collections.

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
5725	Part 610; General requirements		Modified
261939	Annual reporting of released unsuitable units		Unchanged
261240	FDA recommended notifications relating to blood donations and donor suitability determinations		Unchanged
215607	Parts 630 & 640; Blood and blood components intended for transfusion or further manufaturing; additional standards		Modified
187286	Part 606 GMP for blood and blood components		Modified

ICR Details

OMB Control No: 0910-0116	ICR Reference No: 202610-0910-012
Status: Historical Inactive	Previous ICR Reference No: 202308-0910-020
Agency/Subagency: HHS/FDA	Agency Tracking No: CBER
Title: Current Good Manufacturing Practices for Blood and Related Regulations for and Blood Components; and Requirements for Donor Testing, Donor Notification, and "Lookback"
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Emergency	Approval Requested By: 10/30/2026
OIRA Conclusion Action: Improperly submitted and continue	Conclusion Date: 10/28/2026
Retrieve Notice of Action (NOA)	Date Received in OIRA: 10/28/2026
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2026	6 Months From Approved	03/31/2027
Responses	4,455,597	0	4,455,597
Time Burden (Hours)	583,874	0	583,874
Cost Burden (Dollars)	0	0	0

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Abstract: This information collection supports implementation of statutory and regulatory requirements that govern blood and blood components. All blood and blood components introduced or delivered for introduction into interstate commerce are subject to section 351(a) of the Public Health Service Act (PHS Act) (42 U.S.C. 262(a)). FDA administers the information collection to prevent the introduction, transmission, or spread of communicable diseases through blood or blood components.

Emergency Justfication: Please see attached justification. Thank you.

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Authorizing Statute(s): US Code: 42 USC 262 Name of Law: Public Health: Regulation of biological products
   US Code: 21 USC 301 et seq. Name of Law: Federal Food, Drug and Cosmetic 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
	Other Documents for OIRA Review

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Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 5

table that charts list of burden

IC Title	Form No.	Form Name
Annual reporting of released unsuitable units
FDA recommended notifications relating to blood donations and donor suitability determinations
Part 606 GMP for blood and blood components
Part 610; General requirements
Parts 630 & 640; Blood and blood components intended for transfusion or further manufaturing; additional standards

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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: Upon review of current data, we have adjusted the number of respondents downward resulting in 668 fewer burden hours and 338,755 fewer responses annually. We attribute the reduction in responses to previous double-counting of reporting and recordkeeping tasks and have reorganized the information collection elements to align with the applicable regulatory requirements to avoid future errors. We are currently awaiting public comment on our proposed extension and will make any adjustments based on public comment accordingly.

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Annual Cost to Federal Government: $2,836,116

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.     No

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: 10/28/2026

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