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 201701-0910-007

OMB: 0910-0458

Federal Form Document

ICR Details
0910-0458 201701-0910-007
Historical Active 201312-0910-008
HHS/FDA CBER
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 with change 02/17/2017
Retrieve Notice of Action (NOA) 01/12/2017
  Inventory as of this Action Requested Previously Approved
02/29/2020 36 Months From Approved 02/28/2017
48,930 0 58,653
93,854 0 112,499
0 0 0

This information collection supports agency regulations regarding the reporting of biological product deviations and human cells, tissues, and cellular and tissue-based product deviations. Respondents to the collection are manufacturers of these products. The information collection supports the agency's mission to protect the public health.

US Code: 21 USC 351 Name of Law: Adulterated Drugs and Devices
   PL: Pub.L. 78 - 410 351 Name of Law: Public Health Service Act; Biological Products
  
None

Not associated with rulemaking

  81 FR 36550 06/07/2016
81 FR 79504 11/14/2016
Yes

  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 48,930 58,653 0 0 -9,723 0
Annual Time Burden (Hours) 93,854 112,499 0 0 -18,645 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Miscellaneous Actions
Yes
Miscellaneous Actions
This information collection reflects an overall reduction we attribute to fewer respondents. We discuss this more fully in our supporting statement at Q15.

$831,565
No
No
No
No
No
Uncollected
Domini Bean 301 796-5733 domini.bean@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.
01/12/2017


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