Adverse Experience Reporting for Licensed Biological Product; and General Records

Forms and Documents

Document Name	Status
0308ss4-29-08.doc Supporting Statement A	2008-07-14

IC Document Collections

IC ID	Document Title	Status
5877	Adverse Experience Reporting for Licensed Biological Product; and General Records	Modified
185792	Adverse Experience Reporting for Licensed Biological Product; and General Records	New
185791	Adverse Experience Reporting for Licensed Biological Product; and General Records	New
185790	Adverse Experience Reporting for Licensed Biological Product; and General Records	New
185789	Adverse Experience Reporting for Licensed Biological Product; and General Records	New
185788	Adverse Experience Reporting for Licensed Biological Product; and General Records	New
185787	Adverse Experience Reporting for Licensed Biological Product; and General Records	New

ICR Details

OMB Control No: 0910-0308	ICR Reference No: 200807-0910-007
Status: Historical Active	Previous ICR Reference No: 200505-0910-001
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Adverse Experience Reporting for Licensed Biological Product; and General Records
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: 09/23/2008
	Date Received in OIRA: 07/21/2008
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2011	36 Months From Approved	09/30/2008
Responses	98,732	0	22,324
Time Burden (Hours)	895,663	0	493,522
Cost Burden (Dollars)	0	0	0

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Abstract: The AER requirements enable FDA to take actions necessary for the protection of the public health in response to reports of adverse experiences related to licensed biological products. The recordkeeping requirements serve preventative and remedial purposes by requesting accountability and traceability in each step from the manufacture to distribution and recall of products and by enabling FDA to perform meaningful inspections. Respondents to this collection of information are manufacturers of biological products.

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

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:
	73 FR 8881	02/25/2008
30-day Notice:	Federal Register Citation:	Citation Date:
	73 FR 28486	05/16/2008
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 7

IC Title	Form No.	Form Name
Adverse Experience Reporting for Licensed Biological Product; and General Records
Adverse Experience Reporting for Licensed Biological Product; and General Records
Adverse Experience Reporting for Licensed Biological Product; and General Records
Adverse Experience Reporting for Licensed Biological Product; and General Records
Adverse Experience Reporting for Licensed Biological Product; and General Records
Adverse Experience Reporting for Licensed Biological Product; and General Records
Adverse Experience Reporting for Licensed Biological Product; and General Records

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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	98,732	22,324	0	54,536	21,872	0
Annual Time Burden (Hours)	895,663	493,522	0	0	402,141	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: The estimated total annual burden for this information collection was 493,522 hours in 2005. The current increase to 895,639 burden hours is mostly attributed to the increase in the number of reports (total annual responses) submitted under 21 CFR 600.80.

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Annual Cost to Federal Government: $12,500,958

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

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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: 07/21/2008

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