Prescription Drug Product Labeling; Medication Guide Requirements

Forms and Documents

Document Name	Status
pra0393 ss2008.doc Supporting Statement A	2009-03-30

IC Document Collections

IC ID	Document Title	Status
6050	Prescription Drug Product Labeling; Medication Guide Requirements	Modified
188594	Prescription Drug Product Labeling: Medication Guide Requirements	New
187331	Prescription Drug PRoduct Labeling: Medication Guide Requirements	New
187330	Prescription Drug PRoduct Labeling; Medication GUide Requirements	New

ICR Details

OMB Control No: 0910-0393	ICR Reference No: 200811-0910-007
Status: Historical Active	Previous ICR Reference No: 200506-0910-002
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: 04/10/2009
	Date Received in OIRA: 11/28/2008
Terms of Clearance: This ICR is approved as revised. When burden or cost estimates are changing--especially when the changes are large--FDA should provide a more fulsome explanation for why they are changing. In this case, this ICR is approved on the understanding that the number of responses is not actually increasing by 294 million but that the estimate is being revised in light of publicly available information on the annual use of commonly used drugs like antidepressants (and thus, the frequency with which Medication Guides must be dispensed). The additional 2,148,750 additional burden hours is in response to public comments that 208.24(c) does, in fact, carry burden. Finally, this ICR is approved on the understanding that no other changes are being made through this ICR. Per FDA memo of 3/28/09, FDA agrees 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. This ICR revision should be submitted prior to the modifications taking effect.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	04/30/2012	36 Months From Approved	04/30/2009
Responses	296,719,030	0	1,100,000
Time Burden (Hours)	16,907,110	0	4,248
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 314.70 Name of Law: FFDCA
   US Code: 21 USC 208.20 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:
	73 FR 14471	03/18/2008
30-day Notice:	Federal Register Citation:	Citation Date:
	73 FR 72055	11/26/2008
Did the Agency receive public comments on this ICR? Yes

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

IC Title	Form No.	Form Name
Prescription Drug Product Labeling; Medication Guide Requirements
Prescription Drug PRoduct Labeling; Medication GUide Requirements
Prescription Drug PRoduct Labeling: Medication Guide Requirements
Prescription Drug Product Labeling: Medication Guide Requirements

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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	296,719,030	1,100,000	0	1,719,000	293,900,030	0
Annual Time Burden (Hours)	16,907,110	4,248	0	2,148,750	14,754,112	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:

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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]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

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: 11/28/2008

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