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

ICR 201908-0910-003

OMB: 0910-0116

Federal Form Document

Forms and Documents
Justification for No Material/Nonsubstantive Change
Justification for No Material/Nonsubstantive Change
Supporting Statement A
ICR Details
0910-0116 201908-0910-003
Active 201812-0910-006
Current Good Manufacturing Practices for Blood and Related Regulations for and Blood Components; and Requirements for Donor Testing, Donor Notification, and "Lookback"
No material or nonsubstantive change to a currently approved collection   No
Approved without change 08/09/2019
Retrieve Notice of Action (NOA) 08/08/2019
Approved with the understanding that any changes to this collection as a result of finalizing the relevant guidance will be submitted for review and approval in a timely manner.
  Inventory as of this Action Requested Previously Approved
06/30/2021 06/30/2021 06/30/2021
3,109,718 0 3,109,718
504,449 0 504,448
0 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

  83 FR 3165 01/23/2018
83 FR 16870 04/17/2018

  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 3,109,718 3,109,718 0 0 0 0
Annual Time Burden (Hours) 504,449 504,448 0 0 1 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0

Domini Bean 301 796-5733 [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.

© 2022 | Privacy Policy