Adverse Experience Reporting for Licensed Biological Product; and General Records

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form VAERS-1 Vaccine Adverse Event Reporting System	Form and Instruction	Modified	Available
Form 3500A MEDWATCH	Form	Modified	Available
Form VAERS-1 Vaccine Adverse Event Reporting System	Form and Instruction	Modified	Available
Form 3500A MEDWATCH	Form	Modified	Available
Form VAERS-1 Vaccine Adverse Event Reporting System	Form and Instruction	Modified	Available
Form 3500A MEDWATCH	Form	Modified	Available
Form VAERS-1 Vaccine Adverse Event Reporting System	Form and Instruction	Modified	Available
Form 3500A MEDWATCH	Form	Modified	Available
Form VAERS-1 Vaccine Adverse Event Reporting System	Form and Instruction	Modified	Available
Form 3500A MEDWATCH	Form	Modified	Available
Form VAERS-1 Vaccine Adverse Event Reporting System	Form and Instruction	Modified	Available
Form 3500A MEDWATCH	Form	Modified	Available
Form VAERS-1 Vaccine Adverse Event Reporting System	Form and Instruction	Modified	Available
Form 3500A MEDWATCH	Form	Modified	Available
SUPPORTING STATEMENT FINAL 11-3-14.docx	Supporting Statement A	Uploaded 2014-11-03	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
5877	600.80(c)(1) and 600.80(e)	Form and Instruction	Modified	Vaccine Adverse Event Reporting System
5877	600.80(c)(1) and 600.80(e)	Form	Modified	MEDWATCH
185792	600.80(i)	Form and Instruction	Modified	Vaccine Adverse Event Reporting System
185792	600.80(i)	Form	Modified	MEDWATCH
185791	600.12(b)(2)	Form and Instruction	Modified	Vaccine Adverse Event Reporting System
185791	600.12(b)(2)	Form	Modified	MEDWATCH
185790	600.12	Form and Instruction	Modified	Vaccine Adverse Event Reporting System
185790	600.12	Form	Modified	MEDWATCH
185789	600.90	Form and Instruction	Modified	Vaccine Adverse Event Reporting System
185789	600.90	Form	Modified	MEDWATCH
185788	600.81	Form and Instruction	Modified	Vaccine Adverse Event Reporting System
185788	600.81	Form	Modified	MEDWATCH
185787	600.80(c)(2)	Form and Instruction	Modified	Vaccine Adverse Event Reporting System
185787	600.80(c)(2)	Form	Modified	MEDWATCH

ICR Details

OMB Control No: 0910-0308	ICR Reference No: 201410-0910-016
Status: Historical Active	Previous ICR Reference No: 201107-0910-007
Agency/Subagency: HHS/FDA	Agency Tracking No: CBER
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 with change	Conclusion Date: 02/03/2015
Retrieve Notice of Action (NOA)	Date Received in OIRA: 11/10/2014
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/2018	36 Months From Approved	02/28/2015
Responses	459,239	0	296,769
Time Burden (Hours)	4,293,381	0	2,096,444
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. Identification of new and unexpected safety issues through the analysis of the data in the AERS system contributes directly to increased public health protection. The semiannual distribution reports provide FDA with important information about products distributed under biologics licenses, including the quantity, certain lot numbers, labeled date of expiration, the fill lot numbers for the total number of dosage units of each strength or potency distributed ( e.g., 50,000 per 10-milliliter vials), and date of release. This allows FDA to estimate more accurately the incidence of a product's adverse effects in relation to the volume of the product distributed. The recordkeeping requirements serve preventative and remedial purposes by establishing accountability and traceability in the manufacture and distribution of products. These requirements also provide FDA with the necessary information to help ensure the safety, purity, and potency of biological products and enable FDA to perform meaningful inspections. Without this information, FDA could not monitor industry procedures and discharge its statutory responsibility for protecting the nation's health.

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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:
	79 FR 19097	04/07/2014
30-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 64392	10/29/2014
Did the Agency receive public comments on this ICR? Yes

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

table that charts list of burden

IC Title	Form No.	Form Name
600.12	3500A, VAERS-1	MEDWATCH ,   Vaccine Adverse Event Reporting System
600.12(b)(2)	3500A, VAERS-1	MEDWATCH ,   Vaccine Adverse Event Reporting System
600.80(c)(1) and 600.80(e)	3500A, VAERS-1	MEDWATCH ,   Vaccine Adverse Event Reporting System
600.80(c)(2)	3500A, VAERS-1	MEDWATCH ,   Vaccine Adverse Event Reporting System
600.80(i)	3500A, VAERS-1	MEDWATCH ,   Vaccine Adverse Event Reporting System
600.81	3500A, VAERS-1	MEDWATCH ,   Vaccine Adverse Event Reporting System
600.90	3500A, VAERS-1	MEDWATCH ,   Vaccine Adverse Event Reporting System

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ICR Summary of Burden

table that charts list 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	459,239	296,769	0	0	162,470	0
Annual Time Burden (Hours)	4,293,381	2,096,444	0	0	2,196,937	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: The estimated total annual burden for this information collection in 2010 was 2,096,444 hours. The current increase to the total annual burden of 4,293,381 burden hours is mostly attributed to the increase in the number of respondents and total annual responses (number of AER reports) submitted under 21 CFR 600.80(c)(2) and the corresponding recordkeeping requirements under 21 CFR 600.80(i). The increase under these requirements (~ 2,200,000) is due to the normal variation in the submission of AER reports depending on various factors (e.g., new biological products on the market).

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Annual Cost to Federal Government: $83,423,289

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: 11/10/2014

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