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

ICR 202106-0910-004

OMB: 0910-0116

Federal Form Document

Forms and Documents
Supporting Statement A
ICR Details
0910-0116 202106-0910-004
Received in OIRA 201908-0910-003
Current Good Manufacturing Practices for Blood and Related Regulations for and Blood Components; and Requirements for Donor Testing, Donor Notification, and "Lookback"
Revision of a currently approved collection   No
Regular 06/28/2021
  Requested Previously Approved
36 Months From Approved 06/30/2021
4,455,496 3,109,718
583,473 504,449
0 0

This information collection supports FDA regulations. Current good manufacturing practice (CGMP) regulations for donor testing, donor notification, and "lookback" provide FDA with information necessary 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 and initiate recalls. The recordkeeping requirements serve preventative and remedial purposes. The public health objective in testing human blood donors for evidence of infection due to communicable disease agents and in notifying donors is to prevent the transmission of communicable disease.

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

Not associated with rulemaking

  86 FR 10582 02/22/2021
86 FR 33713 06/25/2021

  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 4,455,496 3,109,718 0 0 1,345,778 0
Annual Time Burden (Hours) 583,473 504,449 0 0 79,024 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
We have adjusted our burden estimate for this information collection since last OMB review to reflect an overall increase of 79,024 hours annually. We attribute this adjustment to an increase in the number of registered blood establishments over the last 3 years. Also, for efficiency of agency operations we have consolidated related information collection approved under 0910-0862 and will discontinue the latter collection upon OMB approval of this request.

Amber Sanford 301 796-8867 [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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