Biological Products: Reporting of Biological Product Deviations in Manufacturing; Forms 3486 and 3486A

ICR 200810-0910-006

OMB: 0910-0458

Federal Form Document

ICR Details
0910-0458 200810-0910-006
Historical Active 200703-0910-003
Biological Products: Reporting of Biological Product Deviations in Manufacturing; Forms 3486 and 3486A
No material or nonsubstantive change to a currently approved collection   No
Approved without change 12/23/2008
Retrieve Notice of Action (NOA) 10/29/2008
This request for a non-substantive change is approved. In the future, however, FDA shall provide a more detailed justification statement for why the changes requested are non-substantive. FDA's efforts to minimize burden is appreciated. However, just because changes result in less burden does not automatically mean that a change is non-substantive.
  Inventory as of this Action Requested Previously Approved
06/30/2010 06/30/2010 06/30/2010
44,803 0 44,803
85,873 0 86,407
0 0 0

FDA requires that all licensed manufacturers of biological products other than blood and blood products, all licensed manufacturers of human blood and blood components, including Source Plasma, unlicensed registered blood establishments, and transfusion services report all biological product deviations in manufacturing for distributed products. It provides a more accurate surveillance of the nations blood supply, thereby enabling FDA to monitor actions taken in response to biological product deviations detected for all these establishments. This facilitates a rapid response by FDA where the public health may be at risk.

US Code: 21 USC 351 Name of Law: FFDCA
   US Code: 42 USC 262 Name of Law: PHS Act

Not associated with rulemaking

  71 FR 63772 10/31/2006
72 FR 4267 01/30/2007

  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 44,803 44,803 0 0 0 0
Annual Time Burden (Hours) 85,873 86,407 0 -534 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Miscellaneous Actions
The previous burden estimate was 67,844 hours. The current overall increase in burden to 86,407 hours is attributed to the increase in the number of annual responses as well as the addition of Form FDA 3486A.

Saleda Perryman


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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