Prescription Drug Product Labeling; Medication Guide Requirements

Forms and Documents

Document Name	Status
SUPPORTING STATEMENT 0393 final 1-9-13.doc Supporting Statement A	2013-01-10

IC Document Collections

IC ID	Document Title	Status
6050	Initial Submissions	Modified
205325	Distributing and Dispensing a Medication Guide	New
188594	Exemption/Deferral Requests	Modified
187331	Patient Disclosure	Modified
187330	Revised Submissions	Modified

ICR Details

OMB Control No: 0910-0393	ICR Reference No: 201204-0910-003
Status: Historical Active	Previous ICR Reference No: 200811-0910-007
Agency/Subagency: HHS/FDA	Agency Tracking No:
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: 01/14/2013
	Date Received in OIRA: 04/30/2012
Terms of Clearance: Consistent with prior terms of clearance, FDA is reminded that it will submit an ICR revision if the Medication Guide program is modified in such a way that results in new or different information collection requirements. Any such ICR revisions must be submitted prior to the modifications taking effect.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2016	36 Months From Approved	01/31/2013
Responses	296,719,031	0	296,719,030
Time Burden (Hours)	16,907,114	0	16,907,110
Cost Burden (Dollars)	0	0	0

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Abstract: FDA regulations require the distribution of patient labeling, called Medication Guides, for certain prescription human drugs and biological products used primarily on an outpatient basis that pose a serious and significant public health concern requiring distribution of FDA-approved patient medication information. These Medication Guides inform patients about the most important information they should know about these products in order to use them safely and effectively.

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Authorizing Statute(s): US Code: 21 USC 208.20 Name of Law: FFDCA
   US Code: 21 USC 314.70 Name of Law: FFDCA
  

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:
	76 FR 79194	12/21/2011
30-day Notice:	Federal Register Citation:	Citation Date:
	77 FR 24961	04/26/2012
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
Initial Submissions
Revised Submissions
Patient Disclosure
Exemption/Deferral Requests
Distributing and Dispensing a Medication Guide

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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	296,719,031	296,719,030	0	0	1	0
Annual Time Burden (Hours)	16,907,114	16,907,110	0	0	4	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: The agency estimate change reflects the correction of a typo on the previous submission.

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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: 04/30/2012

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