Reporting of Biological Product Deviations and Human Cells, Tissues, and Cellular and Tissue-Based Product Deviations in Manufacturing

Forms and Documents

Document Name	Status
Form FDA 3486 Reporting of Biological Product Deviations by Licensed Manufacturer Form and Instruction	Modified
Form FDA 3486A Form FDA 3486A; Web-based Addendum Form	Modified
Form FDA 3486 HCT/P deviations Form and Instruction	Modified
Form FDA 3486 Reporting of Product Deviations by Licensed Manufacturers, Unlicensed Registered Blood Establishments, and Transfusion Services Form and Instruction	Modified
0458 Biologics deviations reports SSA 2019 Ext.pdf Supporting Statement A	2020-01-10

IC Document Collections

IC ID	Document Title	Status
6151	Reporting of Biological Product Deviations by Licensed Manufacturer Form and Instruction	Modified
178972	Form FDA 3486A; Web-based Addendum Form	Modified
178971	HCT/P deviations Form and Instruction	Modified
178970	Reporting of Product Deviations by Licensed Manufacturers, Unlicensed Registered Blood Establishments, and Transfusion Services Form and Instruction	Modified

ICR Details

OMB Control No: 0910-0458	ICR Reference No: 201911-0910-003
Status: Active	Previous ICR Reference No: 201701-0910-007
Agency/Subagency: HHS/FDA	Agency Tracking No: CBER
Title: Reporting of Biological Product Deviations and Human Cells, Tissues, and Cellular and Tissue-Based Product Deviations in Manufacturing
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: 01/29/2020
	Date Received in OIRA: 01/10/2020
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2023	36 Months From Approved	02/29/2020
Responses	49,328	0	48,930
Time Burden (Hours)	94,592	0	93,854
Cost Burden (Dollars)	4,256,663	0	0

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Abstract: 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 by safeguarding against the transmission and spread of communicable disease.

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Authorizing Statute(s): 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
  

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:
	84 FR 37321	07/31/2019
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 70979	12/26/2019
Did the Agency receive public comments on this ICR? Yes

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

IC Title	Form No.	Form Name
Reporting of Biological Product Deviations by Licensed Manufacturer	FDA 3486	Biological Product Deviation Report
Reporting of Product Deviations by Licensed Manufacturers, Unlicensed Registered Blood Establishments, and Transfusion Services	FDA 3486	Biological Product Deviation Report
HCT/P deviations	FDA 3486	Biological Product Deviation Report
Form FDA 3486A; Web-based Addendum	FDA 3486A	Biological Product Deviation Report; web-based Addendum

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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	49,328	48,930	0	0	398	0
Annual Time Burden (Hours)	94,592	93,854	0	0	738	0
Annual Cost Burden (Dollars)	4,256,663	0	0	0	4,256,663	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 estimated burden for the information collection reflects an overall increase of 738 hours and a corresponding increase of 398 responses. We attribute this adjustment to an increase in the number of submissions we received over the last few years.

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Annual Cost to Federal Government: $879,025

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

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     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: 01/10/2020

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