FDA Adverse Event Reports; Electronic Submissions

Forms and Documents

Document Name	Status
0645 SS 2016.pdf Supporting Statement A	2016-02-29

IC Document Collections

IC ID	Document Title	Status
192363	Mandatory and voluntary RFR (human and animal) via SRP	Modified
192362	Mandatory Adverse Event Reporting via ESG (Gateway-to-Gateway transmission)	Modified
192361	Mandatory Adverse Event Reporting via the SRP (other than RFR reports) Other-(Screen shots for CVM collection)	Modified
192360	Voluntary Adverse Event Reporting via the SRP (other than RFR reports) Other-eForm Submission	Modified

ICR Details

OMB Control No: 0910-0645	ICR Reference No: 201602-0910-009
Status: Historical Active	Previous ICR Reference No: 201409-0910-012
Agency/Subagency: HHS/FDA	Agency Tracking No: AGENCY WIDE
Title: FDA Adverse Event Reports; Electronic Submissions
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: 05/04/2016
	Date Received in OIRA: 02/29/2016
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2019	36 Months From Approved	05/31/2016
Responses	1,867,657	0	1,494,577
Time Burden (Hours)	1,120,849	0	897,001
Cost Burden (Dollars)	0	0	0

---

Abstract: This ICR collects both mandatory and voluntary information regarding adverse events associated with FDA-regulated products that are submitted electronically using agency data-collection applications. Because the agency continues to move from a paper/manual submissions process for reporting adverse events to an electronic systems process, the scope of the ICR is limited to those product areas for which an electronic portal has been developed. Respondents include both manufacturers and distributers of FDA products, as well as individual consumers. The information collected enables FDA to identify potential public health threats and implement mitigation strategies as appropriate.

---

Authorizing Statute(s): US Code: 21 USC 355 Name of Law: FFDCA
   US Code: 21 USC 357 Name of Law: FFDCA
   US Code: 21 USC 360 Name of Law: FFDCA
   US Code: 21 USC 393 Name of Law: FFDCA
   US Code: 21 USC 301 Name of Law: FFDCA
   PL: Pub.L. 109 - 462 120 Name of Law: DSNDCPA
   PL: Pub.L. 110 - 85 1005 Name of Law: FDAAA
  

Citations for New Statutory Requirements: None

---

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

---

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 72071	11/18/2015
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 10252	02/29/2016
Did the Agency receive public comments on this ICR? No

---

Number of Information Collection (IC) in this ICR: 4

IC Title	Form No.	Form Name
Voluntary Adverse Event Reporting via the SRP (other than RFR reports)
Mandatory Adverse Event Reporting via the SRP (other than RFR reports)
Mandatory Adverse Event Reporting via ESG (Gateway-to-Gateway transmission)
Mandatory and voluntary RFR (human and animal) via SRP

---

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	1,867,657	1,494,577	0	273	372,807	0
Annual Time Burden (Hours)	1,120,849	897,001	0	164	223,684	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: Burden changes reflect fluctuations in adverse event reporting and new electronic reporting features. These changes are discussed more fully in the agency's supporting statement.

---

Annual Cost to Federal Government: $35,485,483

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

---

Common Form ICR:  No

---

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: 02/29/2016

---