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

Forms and Documents

Document Name	Status
Form 3486 Reporting of Biological Product Deviations by Licensed Manufacturers - 600.14 Form and Instruction	Modified
Form 3486A Form FDA 3486A Addendum Form and Instruction	Modified
Form 3486 Reporting - 1271.350(b) Form and Instruction	Modified
Form 3486 Reporting of Product Deviations by Licensed Manufacturers, Unlicensed Registered Blood Establishments, and Transfusion Services - 606.171 Form and Instruction	Modified
SUPPORTING STATEMENT FINAL 12-17-13.doc Supporting Statement A	2013-12-17

IC Document Collections

IC ID	Document Title	Status
6151	Reporting of Biological Product Deviations by Licensed Manufacturers - 600.14 Form and Instruction	Modified
178972	Form FDA 3486A Addendum Form and Instruction	Modified
178971	Reporting - 1271.350(b) Form and Instruction	Modified
178970	Reporting of Product Deviations by Licensed Manufacturers, Unlicensed Registered Blood Establishments, and Transfusion Services - 606.171 Form and Instruction	Modified

ICR Details

OMB Control No: 0910-0458	ICR Reference No: 201312-0910-008
Status: Historical Active	Previous ICR Reference No: 201111-0910-002
Agency/Subagency: HHS/FDA	Agency Tracking No: 21077
Title: Biological Products: Reporting of Biological Product Deviations and Human Cells, Tissues, and Cellular and Tissue-Based Product Deviations; Form FDA 3486 and Addendum 3486A
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 01/27/2014
	Date Received in OIRA: 12/20/2013
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2017	36 Months From Approved	01/31/2014
Responses	58,653	0	46,950
Time Burden (Hours)	112,499	0	90,030
Cost Burden (Dollars)	0	0	0

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Abstract: 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.

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Authorizing Statute(s): US Code: 42 USC 262 Name of Law: PHS Act
   US Code: 21 USC 351 Name of Law: FFDCA
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	78 FR 33846	06/05/2013
30-day Notice:	Federal Register Citation:	Citation Date:
	78 FR 72893	12/04/2013
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 4

IC Title	Form No.	Form Name
Reporting of Product Deviations by Licensed Manufacturers, Unlicensed Registered Blood Establishments, and Transfusion Services - 606.171	3486	Biological Product Deviation Report
Reporting - 1271.350(b)	3486	Biological Product Deviation Report
Form FDA 3486A Addendum	3486A	Biological Product Deviation Report - Addendum
Reporting of Biological Product Deviations by Licensed Manufacturers - 600.14	3486	Biological Product Deviation Report

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ICR Summary of Burden

	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

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: 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.

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Annual Cost to Federal Government: $1,016,531

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Uncollected

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Common Form ICR:  No

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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:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(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;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

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.

Certification Date: 12/20/2013

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