Postmarketing Adverse Drug Experience Reporting

Forms and Documents

Document Name	Status

No forms / supporting documents in this ICR. Check IC Document Collections.

IC Document Collections

IC ID	Document Title	Status
5821	Adverse Drug Experience Reporting -- 310.305(c)(5)	Unchanged
234420	Recordkeeping (21 U.S.C. 379aa(e)(1)	New
234419	Reports of serious adverse drug events (21 U.S.C. 379aa(b)and (c)	New
188678	Adverse Drug Event Recordkeeping -- 314.80(i)	Modified
188677	Adverse Event Recordkeeping -- 310.305(f)	Unchanged
188676	Adverse Event Reporting -- 314.80(c)(2)	Modified
188675	Adverse Event Reporting--314.80(c)(1)(iii)	Unchanged

ICR Details

OMB Control No: 0910-0230	ICR Reference No: 201810-0910-005
Status: Historical Active	Previous ICR Reference No: 201506-0910-031
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Postmarketing Adverse Drug Experience Reporting
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 12/10/2018
	Date Received in OIRA: 12/06/2018
Terms of Clearance: Approved consistent with the understanding that FDA will update OMB Control No. 0910-0636 to reflect the transfer of burden/responses to this control number.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2021	36 Months From Approved	12/31/2018
Responses	1,132,346	0	381,820
Time Burden (Hours)	14,659,976	0	6,724,780
Cost Burden (Dollars)	25,000	0	43,255

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Abstract: FDA regulations require the reporting to FDA of important adverse drug experience information associated with the use of unapproved-marketed prescription drug product. This information is used by FDA to determine at the earliest possible time whether to request a manufacturer, packer, or distributor to recall a product from the market or to recommend a seizure or injunction action to halt the marketing of the product and to remove it from the market. Such action, initiated promptly, may avert further adverse effects that may be associated with the use of the product.

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Authorizing Statute(s): US Code: 21 USC 310.305 Name of Law: Federal Food, Drug, and Cosmetic Act
   US Code: 21 USC 314.80 Name of Law: Federal Food, Drug, and Cosmetic Act
   PL: Pub.L. 109 - 462 2(e)(3) Name of Law: Dietary Supplement and Nonprescription Drug Consumer Protection 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
	Other Documents for OIRA Review

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 40520	08/15/2018
30-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 55901	11/08/2018
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 Drug Experience Reporting -- 310.305(c)(5)
Adverse Event Reporting--314.80(c)(1)(iii)
Adverse Event Reporting -- 314.80(c)(2)
Adverse Event Recordkeeping -- 310.305(f)
Adverse Drug Event Recordkeeping -- 314.80(i)
Reports of serious adverse drug events (21 U.S.C. 379aa(b)and (c)
Recordkeeping (21 U.S.C. 379aa(e)(1)

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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	1,132,346	381,820	0	0	750,526	0
Annual Time Burden (Hours)	14,659,976	6,724,780	0	0	7,935,196	0
Annual Cost Burden (Dollars)	25,000	43,255	0	0	-18,255	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: $0

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: 12/06/2018

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