Prescription Drug Product Labeling; Medication Guide Requirements

Forms and Documents

Document Name	Status
0393 Supporting Statement 2016 REV.pdf Supporting Statement A	2016-09-23

IC Document Collections

IC ID	Document Title	Status
6050	Content and Format of a Medication Guide	Modified
205325	Distributing and Dispensing a Medication Guide to Patients	Modified
188594	Distributor Provides Medication Guide to Dispenser	Modified
187331	Exemptions and Deferrals	Modified
187330	Supplements and Other Changes to an Approved Application	Modified

ICR Details

OMB Control No: 0910-0393	ICR Reference No: 201510-0910-012
Status: Historical Active	Previous ICR Reference No: 201204-0910-003
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Prescription Drug Product Labeling; Medication Guide Requirements
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 with change	Conclusion Date: 09/30/2016
	Date Received in OIRA: 11/12/2015
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2019	36 Months From Approved	09/30/2016
Responses	507,957,166	0	296,719,031
Time Burden (Hours)	27,486,670	0	16,907,114
Cost Burden (Dollars)	0	0	0

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Abstract: This information collection enables the agency to determine whether the labeling for certain prescription drug products that FDA has designated as posing a serious and significant public health concern requiring distribution of FDA-approved patient medication information include Medication Guides that are acceptable to FDA.

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Authorizing Statute(s): None

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 30688	05/29/2015
30-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 67762	11/03/2015
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 5

IC Title	Form No.	Form Name
Content and Format of a Medication Guide
Supplements and Other Changes to an Approved Application
Distributor Provides Medication Guide to Dispenser
Distributing and Dispensing a Medication Guide to Patients
Exemptions and Deferrals

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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	507,957,166	296,719,031	0	0	211,238,135	0
Annual Time Burden (Hours)	27,486,670	16,907,114	0	0	10,579,556	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: Significant burden estimate increase reflected in IC 5. This change due to adjustment in agency estimate is explained more fully at Q 15 of the agency supporting statement.

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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: 11/12/2015

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