Guidance for Industry on Q. & Answers Re: Labeling of Nonprescription Human Drug Products Marketed w/o an Approved App as Required by the Dietary Supp & Nonpresription Drug Consumer Protection Act

Forms and Documents

Document Name	Status
SUPPORTING STATEMENT 0641 FINAL 3-2-2016.doc Supporting Statement A	2016-03-02

IC Document Collections

IC ID	Document Title	Status
188840	Domestic Address or Phone Number Labeling Requirement (21 U.S.C. 502(x)) and Recommendation to Clarify its Purpose Other-Guidance	Modified

ICR Details

OMB Control No: 0910-0641	ICR Reference No: 201602-0910-011
Status: Historical Active	Previous ICR Reference No: 201303-0910-001
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Guidance for Industry on Q. & Answers Re: Labeling of Nonprescription Human Drug Products Marketed w/o an Approved App as Required by the Dietary Supp & Nonpresription Drug Consumer Protection Act
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: 06/20/2016
	Date Received in OIRA: 03/02/2016
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2019	36 Months From Approved	06/30/2016
Responses	900	0	100,000
Time Burden (Hours)	3,600	0	400,000
Cost Burden (Dollars)	0	0	0

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Abstract: This information collection approval request is for a Food and Drug Administration (FDA) guidance for industry entitled “Questions and Answers Regarding the Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act.” The Guidance identifies safety reporting requirements for nonprescription drug products that are marketed without an approved application, and the requirements that the manufacturer, packer, or distributor whose name appears on the label of a nonprescription drug marketed in the United States without an approved application submit to FDA any report of a serious adverse event associated with such drug when used in the United States, accompanied by a copy of the label on or within the retail package of such drug. The Guidance also identifies that the label of a nonprescription drug product marketed without an approved application in the United States include a domestic address or domestic telephone number through which the responsible person may receive a report of a serious adverse event associated with the product. The safety information collected relates to certain nonprescription human drug products required from manufacturers, packers, or distributors so that FDA can take appropriate action to protect the public health when necessary.

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Authorizing Statute(s): PL: Pub.L. 109 - 462 760 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

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 42502	07/17/2015
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 8507	02/19/2016
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Domestic Address or Phone Number Labeling Requirement (21 U.S.C. 502(x)) and Recommendation to Clarify its Purpose

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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	900	100,000	0	0	-99,100	0
Annual Time Burden (Hours)	3,600	400,000	0	0	-396,400	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: There is a significant adjustment in burden for this ICR from 400,000 to 3,600 total burden hours. This adjustment was required to eliminate double-counting of burden hours discovered in OMB Control #0910-0641 and 0910-0340. For 0910-0641, we have limited the third party disclosure burden to new OTC drug products marketed without approved new drug applications.

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Annual Cost to Federal Government: $0

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

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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: 03/02/2016

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