Current Good Manufacturing Practices for Blood and Related Regulations for and Blood Components

ICR 201201-0910-001

OMB: 0910-0116

Federal Form Document

Forms and Documents
Supporting Statement A
ICR Details
0910-0116 201201-0910-001
Historical Active 200811-0910-006
Current Good Manufacturing Practices for Blood and Related Regulations for and Blood Components
Extension without change of a currently approved collection   No
Approved with change 04/09/2012
Retrieve Notice of Action (NOA) 01/03/2012
OMB notes compliance with the prior terms of clearance.
  Inventory as of this Action Requested Previously Approved
04/30/2015 36 Months From Approved 04/30/2012
3,206,393 0 3,011,033
506,637 0 426,913
0 0 0

The information collection requirements in the CGMP, donor testing, donor notification, and "lookback" regulations provide FDA with the necessary information to perform its duty to ensure the safety, purity, and potency of blood and blood components. These requirements establish accountability and traceability in the processing and handling of blood and blood components and enable FDA to perform meaningful inspections. The recordkeeping requirements serve preventative and remedial purposes. The disclosure requirements identify the various blood and blood components and important properties of the product, demonstrate that the CGMP requirements have been met, and facilitate the tracing back of a product to its original source. The reporting requirements inform FDA of any deviations that occur and that may require immediate corrective action.

US Code: 42 USC 351 Name of Law: PHS Act
   US Code: 21 USC 321 Name of Law: FFDCA

Not associated with rulemaking

  76 FR 45262 07/28/2011
76 FR 79692 12/22/2011

  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 3,206,393 3,011,033 0 0 195,360 0
Annual Time Burden (Hours) 506,637 426,913 0 0 79,724 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
The current increase to 506,637 burden hours (an increase of 79,724 hours) is attributed to an increase in the number of total annual records under § 606.160, which was due to an increase in the number of donations for both Whole Blood and Source Plasma.

ILa Mizrachi 301 796-7726 [email protected]


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:
    (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;
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.

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