Adverse Experience Reporting for Licensed Biological Product; and General Records

Forms and Documents

Document Name	Status
0910-0308 - Supporting Statement - 7_11_2011.doc Supporting Statement A	2011-07-11

IC Document Collections

IC ID	Document Title	Status
5877	600.80(c)(1) and 600.80(e)	Modified
185792	600.80(i)	Modified
185791	600.12(b)(2)	Modified
185790	600.12	Modified
185789	600.91	Modified
185788	600.81	Modified
185787	600.80(c)(2)	Modified

ICR Details

OMB Control No: 0910-0308	ICR Reference No: 201107-0910-007
Status: Historical Active	Previous ICR Reference No: 200807-0910-007
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: 11/06/2011
	Date Received in OIRA: 07/19/2011
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2014	36 Months From Approved	11/30/2011
Responses	296,769	0	98,732
Time Burden (Hours)	2,096,444	0	895,663
Cost Burden (Dollars)	0	0	0

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Abstract: The primary purpose of FDA's Adverse Experience Reporting (AER) system is to identify potentially serious safety problems with licensed biological products, focusing especially on newly licensed products. Although premarket testing discloses a general safety profile of a new drug's comparatively common adverse effects, the larger and more diverse patient populations exposed to the licensed biological product provides, for the first time, the opportunity to collect information on rare, latent, and long-term effects. AER reports are obtained from a variety of sources, including manufacturers, patients, physicians, foreign regulatory agencies, and clinical investigators. The general recordkeeping provisions require manufacturers of licensed biological products for human use to maintain records of each step in the manufacture and distribution of products. The recordkeeping requirements serve preventative and remedial purposes by establishing accountability and traceability in the manufacture and distribution of 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:
	76 FR 22401	04/21/2011
30-day Notice:	Federal Register Citation:	Citation Date:
	76 FR 41504	07/14/2011
Did the Agency receive public comments on this ICR? Yes

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

IC Title	Form No.	Form Name
600.80(c)(1) and 600.80(e)
600.80(c)(2)
600.81
600.91
600.12
600.12(b)(2)
600.80(i)

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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	296,769	98,732	0	0	198,037	0
Annual Time Burden (Hours)	2,096,444	895,663	0	0	1,200,781	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:

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Annual Cost to Federal Government: $35,971,982

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: 07/19/2011

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