Biological Products - general records and postmarket adverse experience reporting

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	Removed	Available
Form 3500A MEDWATCH	Form	Removed	Available
Form VAERS-1 Vaccine Adverse Event Reporting System	Form and Instruction	Removed	Available
Form 3500A MEDWATCH	Form	Removed	Available
Form VAERS-1 Vaccine Adverse Event Reporting System	Form and Instruction	Removed	Available
Form 3500A MEDWATCH	Form	Removed	Available
Form VAERS-1 Vaccine Adverse Event Reporting System	Form and Instruction	Removed	Available
Form 3500A MEDWATCH	Form	Removed	Available
Form VAERS-1 Vaccine Adverse Event Reporting System	Form and Instruction	Removed	Available
Form 3500A MEDWATCH	Form	Removed	Available
Form VAERS-1 Vaccine Adverse Event Reporting System	Form and Instruction	Modified	Available
Form 3500A MEDWATCH	Form	Modified	Available
0308 AERs for BLAs SSA 2018 Ext.pdf	Supporting Statement A	Uploaded 2018-02-10	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
5877	Biological products; reporting under 21 CFR Part 600	Form and Instruction	Modified	Vaccine Adverse Event Reporting System
5877	Biological products; reporting under 21 CFR Part 600	Form	Modified	MEDWATCH
185792	600.80(i)	Form and Instruction	Removed	Vaccine Adverse Event Reporting System
185792	600.80(i)	Form	Removed	MEDWATCH
185791	600.12(b)(2)	Form and Instruction	Removed	Vaccine Adverse Event Reporting System
185791	600.12(b)(2)	Form	Removed	MEDWATCH
185790	600.12	Form and Instruction	Removed	Vaccine Adverse Event Reporting System
185790	600.12	Form	Removed	MEDWATCH
185789	600.90	Form and Instruction	Removed	Vaccine Adverse Event Reporting System
185789	600.90	Form	Removed	MEDWATCH
185788	600.81	Form and Instruction	Removed	Vaccine Adverse Event Reporting System
185788	600.81	Form	Removed	MEDWATCH
185787	Biological products; recordkeeping under 21 CFR Part 600	Form and Instruction	Modified	Vaccine Adverse Event Reporting System
185787	Biological products; recordkeeping under 21 CFR Part 600	Form	Modified	MEDWATCH

ICR Details

OMB Control No: 0910-0308	ICR Reference No: 201801-0910-009
Status: Historical Active	Previous ICR Reference No: 201410-0910-016
Agency/Subagency: HHS/FDA	Agency Tracking No: CBER
Title: Biological Products - general records and postmarket adverse experience reporting
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: 04/27/2018
Retrieve Notice of Action (NOA)	Date Received in OIRA: 02/13/2018
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	04/30/2021	36 Months From Approved	04/30/2018
Responses	620,462	0	459,239
Time Burden (Hours)	5,732,514	0	4,293,381
Cost Burden (Dollars)	0	0	0

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Abstract: This information collection supports Food and Drug Administration (FDA) regulations regarding certain general requirements and postmarket adverse experience reporting for biological products. Respondents to the collection are manufacturers of these products subject to the applicable regulations. The information collection enables FDA to implement public health protection provisions of the Federal Food, Drug, and Cosmetic Act.

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Authorizing Statute(s): US Code: 42 USC 262 Name of Law: PHS Act
   US Code: 21 USC 301 et seq. Name of Law: FFDCA
  

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:
	82 FR 32836	07/18/2017
30-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 819	01/08/2018
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 2

table that charts list of burden

IC Title	Form No.	Form Name
600.12	VAERS-1, 3500A	MEDWATCH ,   Vaccine Adverse Event Reporting System
600.12(b)(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
Biological products; recordkeeping under 21 CFR Part 600	3500A, VAERS-1	MEDWATCH ,   Vaccine Adverse Event Reporting System
Biological products; reporting under 21 CFR Part 600	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	620,462	459,239	0	0	161,223	0
Annual Time Burden (Hours)	5,732,514	4,293,381	0	0	1,439,133	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: $83,423,289

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     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: 02/13/2018

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