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

Document Name	Status

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

IC Document Collections

IC ID	Document Title	Status
5725	CGMP for Blood and Blood Components: Reporting Requirements	Unchanged
261939	Annual reporting of released unsuitable units Other-Agency Guidance	New
261240	FDA recommended notifications relating to blood donations and donor suitability determinations Other-Agency Guidance	Unchanged
215607	CGMP for Blood and Blood Components: 3rd Party Disclosures Other-Agency Guidance	Unchanged
187286	CGMP for Blood and Blood Components: Recordkeeping Requirements	Unchanged

ICR Details

OMB Control No: 0910-0116	ICR Reference No: 202308-0910-020
Status: Received in OIRA	Previous ICR Reference No: 202307-0910-004
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: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 08/30/2023

	Requested	Previously Approved
Expiration Date	36 Months From Approved	08/31/2026
Responses	4,455,597	4,455,497
Time Burden (Hours)	583,874	583,474
Cost Burden (Dollars)	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.

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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
60-day Notice:	Federal Register Citation:	Citation Date:
	87 FR 31440	05/24/2022
30-day Notice:	Federal Register Citation:	Citation Date:
	88 FR 57956	08/24/2023
Did the Agency receive public comments on this ICR? Yes

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

IC Title	Form No.	Form Name
Annual reporting of released unsuitable units
CGMP for Blood and Blood Components: 3rd Party Disclosures
CGMP for Blood and Blood Components: Recordkeeping Requirements
CGMP for Blood and Blood Components: Reporting Requirements
FDA recommended notifications relating to blood donations and donor suitability determinations

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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	4,455,597	4,455,497	0	0	100	0
Annual Time Burden (Hours)	583,874	583,474	0	0	400	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: We have revised the information collection to add the draft guidance for industry entitled “Compliance Policy Regarding Blood and Blood Component Donation Suitability, Donor Eligibility and Source Plasma Quarantine Hold Requirements” as discussed at Question-1 and we have made nominal adjustments in burden as enumerated in Question-12a. The result is an increase of 100 responses and 400 hours annually to the information collection.

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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: 08/30/2023

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