Guidance for Industry on Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application

Forms and Documents

Document Name	Status
Guidance - 0910-0636 .pdf Supplementary Document	2012-06-05
Supporting Statement A - 0910-0636_2012.doc Supporting Statement A	2012-06-05

IC Document Collections

IC ID	Document Title	Status
186861	Recordkeeping - (21 U.S.C. 379aa(e)(1))	Modified
186860	Reports of serious adverse drug events (21 U.S.C. 379aa((b) and (c))	Modified

ICR Details

OMB Control No: 0910-0636	ICR Reference No: 201206-0910-002
Status: Historical Active	Previous ICR Reference No: 200810-0910-002
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Guidance for Industry on Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application
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: 08/15/2012
	Date Received in OIRA: 06/08/2012
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2015	36 Months From Approved	08/31/2012
Responses	32,500	0	32,500
Time Burden (Hours)	125,000	0	125,000
Cost Burden (Dollars)	0	0	0

---

Abstract: This guidance provides information on: (1) the meaning of "domestic Address" for purposes of the labeling requirements of section 502(x) of the act; (2) FDA's recommendation for the use of an introductory statement before the domestic address or phone number that is required to appear on the product label under section 502(x)of the act.

---

Authorizing Statute(s): US Code: 21 USC 379aa Name of Law: ffdca
  

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:
	76 FR 80945	12/27/2011
30-day Notice:	Federal Register Citation:	Citation Date:
	77 FR 31024	05/24/2012
Did the Agency receive public comments on this ICR? No

---

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

IC Title	Form No.	Form Name
Reports of serious adverse drug events (21 U.S.C. 379aa((b) and (c))
Recordkeeping - (21 U.S.C. 379aa(e)(1))

---

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	32,500	32,500	0	0	0	0
Annual Time Burden (Hours)	125,000	125,000	0	0	0	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:

---

Annual Cost to Federal Government: $23,000,000

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: 06/08/2012

---