Biological Products: Reporting of Biological Product Deviations and Human Cells, Tissues, and Cellular and Tissue-Based Product Deviations; Form FDA 3486 and Addendum 3486A

ICR 201312-0910-008

OMB: 0910-0458

Federal Form Document

ICR Details
0910-0458 201312-0910-008
Historical Active 201111-0910-002
HHS/FDA 21077
Biological Products: Reporting of Biological Product Deviations and Human Cells, Tissues, and Cellular and Tissue-Based Product Deviations; Form FDA 3486 and Addendum 3486A
Extension without change of a currently approved collection   No
Regular
Approved without change 01/27/2014
Retrieve Notice of Action (NOA) 12/20/2013
  Inventory as of this Action Requested Previously Approved
01/31/2017 36 Months From Approved 01/31/2014
58,653 0 46,950
112,499 0 90,030
0 0 0

FDA requires certain manufacturers to report all biological product deviations (BPDs) and human cells, tissues, and cellular and tissue based products (HCT/P) deviations in manufacturing for distributed products. The objectives of the BPD reporting and HCT/P deviation reporting requirements are to: (1) Enable FDA to respond when public health may be at risk; (2) expedite reporting of BPD and HCT/P deviations in manufacturing; (3) provide FDA with uniform data to track trends that may indicate broader threats to the public health; (4) create a uniform reporting requirement that can be enforced against non-complying entities; and (5) help ensure that licensed manufacturers and unlicensed blood establishments as well as manufacturers of HCT/Ps are taking appropriate actions to investigate and correct biological product deviations. Reporting of BPDs and HCT/P deviations will also enable FDA to identify areas in which further regulation or guidance is needed to assist licensed manufacturers and unlicensed blood establishments as well as non-reproductive HCT/P establishments in decreasing the occurrence of these events. Form FDA 3486 and 3486A were developed to facilitate FDA's review of the BPD and HCT/P deviation reports.

US Code: 42 USC 262 Name of Law: PHS Act
   US Code: 21 USC 351 Name of Law: FFDCA
  
None

Not associated with rulemaking

  78 FR 33846 06/05/2013
78 FR 72893 12/04/2013
No

  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 58,653 46,950 0 0 11,703 0
Annual Time Burden (Hours) 112,499 90,030 0 0 22,469 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
The previous burden estimate in 2010 was 90,029.50 hours. The current overall increase (-22,455 hours) in burden to 112,485 hours is mostly attributed to the increase in the number of respondents and number of annual responses under section 606.171 (21,644 burden hours). The increase is mostly due to the normal variation in submissions of BPDs to FDA.

$1,016,531
No
No
No
No
No
Uncollected
ILa Mizrachi 301 796-7726 ila.mizrachi@fda.hhs.gov

  No

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.
12/20/2013


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