Toll-Free Number for Consumer Reporting of Drug Product Side Effects: Comprehension

Forms and Documents

Document Name	Status
Attachment A Draft Screener and Questionnaire 062607revised.final.doc Supplementary Document	2007-06-29
Attachment B Toll-freestimuli.pdf Supplementary Document	0000-00-00
Attachment A Draft Screener and Questionnaire 113006final.doc Supplementary Document	0000-00-00
TollFreeOMBStatement062607revised.final.doc Supporting Statement A	2007-06-29

IC Document Collections

IC ID	Document Title	Status
178832	Toll-Free Number for Consumer Reporting of Drug Product Side Effects: Comprehension	New
178831	Toll-Free Number for Consumer Reporting of Drug Product Side Effects: Comprehension	New

ICR Details

OMB Control No: 0910-0603	ICR Reference No: 200702-0910-013
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Toll-Free Number for Consumer Reporting of Drug Product Side Effects: Comprehension
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Emergency	Approval Requested By: 04/02/2007
OIRA Conclusion Action: Approved with change	Conclusion Date: 07/03/2007
	Date Received in OIRA: 02/22/2007
Terms of Clearance: If changes to the questionnaire and related materials are made after pre-testing, FDA shall submit the final versions for OMB approval via ROCIS. The study design is appropriate for the purpose of the study identified in the supporting statement. However, in describing the data collected and results of the analysis, FDA will clearly acknowledge that the data does not provide nationally representative estimates of consumer attitudes, knowledge, behaviors, etc.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2008	6 Months From Approved
Responses	3,284	0	0
Time Burden (Hours)	257	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: Section 17 of the Best Pharmaceuticals for Children Act required FDA to issue a final rule mandating the addition of a statement to the labeling of each drug product for which an application is approved under section 505 of the FFDCA. Under the BPCA the statements must include (1) a toll-free number for consumers to use to report drug product side effects, and (2) a statement that the number is to be used only for reporting side effects and is not intended to seek or obtain medical advice (the side effects statement).

Emergency Justfication: The information that will be collected is needed prior to the expiration of the normal time period for OMB clearance. Section 17 of the BPCA(Public Law 107-109)- requires FDA to issue a final rule mandating the addition of a statment to the labeling of each drug product for which an applicaiton is approved under section 505 of "the act". THe use of the normal clearance procedures would futher delay FDA's issuance of a final rule to comply with this congressional mandate.

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Authorizing Statute(s): PL: Pub.L. 107 - 109 17 Name of Law: BPCA
  

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
30-day Notice:	Federal Register Citation:	Citation Date:
	72 FR 22	02/02/2007
Did the Agency receive public comments on this ICR? No

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

IC Title	Form No.	Form Name
Toll-Free Number for Consumer Reporting of Drug Product Side Effects: Comprehension
Toll-Free Number for Consumer Reporting of Drug Product Side Effects: Comprehension

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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	3,284	0	0	3,284	0	0
Annual Time Burden (Hours)	257	0	0	257	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: This is a new burden estimate due the agency receiving comments on a proposed rule regarding side effects statements for certain prescription drug product labeling. The FDA conducted two focus groups to narrow the field of potential statement alternatives now will conduct this proposed study on the Internet.

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Annual Cost to Federal Government: $24

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)? Uncollected

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: 02/22/2007

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