Revisions to Labeling Requirements for Blood and Blood Components, Including Source Plasma

ICR 201205-0910-003

OMB: 0910-0723

Federal Form Document

Forms and Documents
Supporting Statement A
ICR Details
0910-0723 201205-0910-003
Historical Active
Revisions to Labeling Requirements for Blood and Blood Components, Including Source Plasma
New collection (Request for a new OMB Control Number)   No
Approved without change 09/14/2012
Retrieve Notice of Action (NOA) 05/07/2012
At the time of expiration, FDA will fold this collection into the supporting statement for 0910-0116. At that time, the 1 hour burden "placeholder" will no longer be necessary, but FDA should retain a description of the labeling requirements associated with this final rule.
  Inventory as of this Action Requested Previously Approved
04/30/2015 36 Months From Approved
1 0 0
1 0 0
0 0 0

FDA is finalizing the labeling requirements for blood or blood components intended for use in transfusion or for further manufacture pursuant to the provisions of the Public Health Service Act (PHS Act) (42 U.S.C. 262-264), and the drugs, devices, and general administrative provisions of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 331, 351-353, 355, 360, 360j, 371, and 374). Under these provisions of the PHS Act and the Federal Food, Drug, and Cosmetic Act, we have the authority to issue and enforce regulations designed to ensure that biological products are safe, pure, potent, and properly labeled, and to prevent the introduction, transmission, and spread of communicable disease.

US Code: 21 USC 606.121 Name of Law: null

0910-AF26 Final or interim final rulemaking 77 FR 7 01/03/2012

  76 FR 82300 12/30/2011
77 FR 24720 04/25/2012

IC Title Form No. Form Name
Revisions to Labeling Requirements for Blood and Blood Components, Including Source Plasma

  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 1 0 0 1 0 0
Annual Time Burden (Hours) 1 0 0 1 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Changing Regulations
There is no burden associated with this information collection as FDA believes that it is usual and customary to the respondents. We are estimating one burden hour for the purpose of entering this ICR in ICRAS.

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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