Postmarketing Adverse Drug Experience Reporting

Forms and Documents

Document Name	Status
0230 AER for Drugs SSA 2021 REV.docx Supporting Statement A	2021-11-21

IC Document Collections

IC ID	Document Title	Status
5821	AER Rx products not subject of marketing application	Modified
250441	GFI: Providing PSURs Other-Agency Guidance	New
250440	GFI: AER and Records During Pandemic Other-Agency Guidance	New
234420	AER records under FFDCA 760(e)(1) (21 U.S.C. 379aa(e)(1)) Other-Agency Guidance	Modified
234419	AER under FFDCA sec. 760 - nonprescription drug products Other-Agency Guidance	Modified
188678	AER records under 314.80 (marketing applications)	Modified
188677	AER records for Rx products not subject of marketing application	Modified
188676	AER under 314.80 (marketing applications) - quarterly reports Other-Agency Guidance	Modified
188675	AER under 314.80 (marketing applications) - 15 day alerts	Modified

ICR Details

OMB Control No: 0910-0230	ICR Reference No: 202110-0910-003
Status: Received in OIRA	Previous ICR Reference No: 202105-0910-002
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	Date Submitted to OIRA: 11/22/2021

	Requested	Previously Approved
Expiration Date	36 Months From Approved	12/31/2021
Responses	1,136,229	1,139,100
Time Burden (Hours)	14,703,589	14,922,297
Cost Burden (Dollars)	0	25,000

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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): PL: Pub.L. 109 - 462 2(e)(3) Name of Law: Dietary Supplement and Nonprescription Drug Consumer Protection Act
   US Code: 21 USC 321, 352, 355, 371, 379aa Name of Law: FFDCA; Adverse Event Reporting
  

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:
	86 FR 34759	06/30/2021
30-day Notice:	Federal Register Citation:	Citation Date:
	86 FR 61277	11/05/2021
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 9

IC Title	Form No.	Form Name
AER Rx products not subject of marketing application
AER records for Rx products not subject of marketing application
AER records under 314.80 (marketing applications)
AER records under FFDCA 760(e)(1) (21 U.S.C. 379aa(e)(1))
AER under 314.80 (marketing applications) - 15 day alerts
AER under 314.80 (marketing applications) - quarterly reports
AER under FFDCA sec. 760 - nonprescription drug products
GFI: AER and Records During Pandemic
GFI: Providing PSURs

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ICR Summary of Burden

	Total Request	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	1,136,229	1,139,100	0	0	-2,871	0
Annual Time Burden (Hours)	14,703,589	14,922,297	0	0	-218,708	0
Annual Cost Burden (Dollars)	0	25,000	0	0	-25,000	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 information collection reflects both program changes and adjustments. For efficiency of agency operations we have revised the ICR to include and account for burden we attribute to reporting and recordkeeping discussed in agency guidance documents and previously approved in separate ICRs; and we have adjusted estimates to reflect fewer reports for nonprescription drug products. We also removed costs reflected in burden summary as we include in these in 12b of our supporting 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? No

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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: 11/22/2021

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