Biological Products: Reporting of Biological Product Deviations in Manufacturing; Forms 3486 and 3486A

Forms and Documents

Document Name	Status
Form 3486 Biological Products: Reporting of Biological Product Deviations in Manufacturing; Forms FDA 3486 and 3486A Form and Instruction	Modified
Form 3486 Biological Products: Reporting of Biolgical Product Deviations in Manufacturing; Forms FDA 3486 and 3486A Form and Instruction	Modified
Form 3486 Biological Products: Reporting of Biological Product Deviations in Manufacturing; Forms FDA 3486 and 3486A Form and Instruction	Modified
Form 3486 Biological Products: Reporting of Biological Product Deviations in Manufacturing; Forms FDA 3486 and 3486A Form and Instruction	Modified
Summary of changes to 3486A ComparisonDoc.doc Supplementary Document	2008-09-26
83-C 0458.doc Justification for No Material/Nonsubstantive Change	2008-09-26
0458 ss 9-2008.doc Supporting Statement A	2008-09-26

IC Document Collections

IC ID	Document Title	Status
6151	Biological Products: Reporting of Biological Product Deviations in Manufacturing; Forms FDA 3486 and 3486A Form and Instruction	Modified
178972	Biological Products: Reporting of Biolgical Product Deviations in Manufacturing; Forms FDA 3486 and 3486A Form and Instruction	Modified
178971	Biological Products: Reporting of Biological Product Deviations in Manufacturing; Forms FDA 3486 and 3486A Form and Instruction	Modified
178970	Biological Products: Reporting of Biological Product Deviations in Manufacturing; Forms FDA 3486 and 3486A Form and Instruction	Modified

ICR Details

OMB Control No: 0910-0458	ICR Reference No: 200810-0910-006
Status: Historical Active	Previous ICR Reference No: 200703-0910-003
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Biological Products: Reporting of Biological Product Deviations in Manufacturing; Forms 3486 and 3486A
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 12/23/2008
	Date Received in OIRA: 10/29/2008
Terms of Clearance: This request for a non-substantive change is approved. In the future, however, FDA shall provide a more detailed justification statement for why the changes requested are non-substantive. FDA's efforts to minimize burden is appreciated. However, just because changes result in less burden does not automatically mean that a change is non-substantive.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2010	06/30/2010	06/30/2010
Responses	44,803	0	44,803
Time Burden (Hours)	85,873	0	86,407
Cost Burden (Dollars)	0	0	0

---

Abstract: FDA requires that all licensed manufacturers of biological products other than blood and blood products, all licensed manufacturers of human blood and blood components, including Source Plasma, unlicensed registered blood establishments, and transfusion services report all biological product deviations in manufacturing for distributed products. It provides a more accurate surveillance of the nations blood supply, thereby enabling FDA to monitor actions taken in response to biological product deviations detected for all these establishments. This facilitates a rapid response by FDA where the public health may be at risk.

---

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

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:
	71 FR 63772	10/31/2006
30-day Notice:	Federal Register Citation:	Citation Date:
	72 FR 4267	01/30/2007
Did the Agency receive public comments on this ICR? No

---

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

IC Title	Form No.	Form Name
Biological Products: Reporting of Biological Product Deviations in Manufacturing; Forms FDA 3486 and 3486A	3486	Biological Product Deviation Report
Biological Products: Reporting of Biological Product Deviations in Manufacturing; Forms FDA 3486 and 3486A	3486	Biological Product Deviation Report
Biological Products: Reporting of Biological Product Deviations in Manufacturing; Forms FDA 3486 and 3486A	3486, FDA 3486A	Biological Product Deviation Report ,   BPDR SUPPLEMENTAL INFORMATION
Biological Products: Reporting of Biolgical Product Deviations in Manufacturing; Forms FDA 3486 and 3486A	3486, FDA 3486A, FDA 3486A	Biological Product Deviation Report ,   BPDR SUPPLEMENTAL INFORMATION ,   Recall Classification

---

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	44,803	44,803	0	0	0	0
Annual Time Burden (Hours)	85,873	86,407	0	-534	0	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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: The previous burden estimate was 67,844 hours. The current overall increase in burden to 86,407 hours is attributed to the increase in the number of annual responses as well as the addition of Form FDA 3486A.

---

Annual Cost to Federal Government: $806

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]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? Uncollected

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: 10/29/2008

---