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
0458 SS 2017 Extension.docx.pdf Supporting Statement A	2017-01-12

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: 201701-0910-007
Status: Historical Active	Previous ICR Reference No: 201312-0910-008
Agency/Subagency: HHS/FDA	Agency Tracking No: CBER
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 with change	Conclusion Date: 02/17/2017
	Date Received in OIRA: 01/12/2017
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/29/2020	36 Months From Approved	02/28/2017
Responses	48,930	0	58,653
Time Burden (Hours)	93,854	0	112,499
Cost Burden (Dollars)	0	0	0

---

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.

---

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

---

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

---

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 36550	06/07/2016
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 79504	11/14/2016
Did the Agency receive public comments on this ICR? Yes

---

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

IC Title	Form No.	Form Name
Reporting of Biological Product Deviations by Licensed Manufacturers - 600.14	3486	Biological Product Deviation Report
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

---

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	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

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: This information collection reflects an overall reduction we attribute to fewer respondents. We discuss this more fully in our supporting statement at Q15.

---

Annual Cost to Federal Government: $831,565

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

---

Common Form ICR:  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:

(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: 01/12/2017

---