Understanding Patients Knowledge and Use of Acetaminophen Phase 2

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form Form #5 Telephone Screener	Form and Instruction	New	Repair queued
Form Form #4 Surveys with Adults (greater than 65 years)	Form and Instruction	New	Repair queued
Form Form #3 Surveys with Adults (20 to 65 years)	Form and Instruction	New	Repair queued
Form Form #2 Surveys with Adolescents(13 to 20 years of age)	Form and Instruction	New	Repair queued
Form Form #1 Surveys with Parents of children	Form and Instruction	New	Repair queued
Supporting Statement Part B -- Understanding Patients Knowledge and Use of Acetaminophen phase 2 9-22-2010.doc	Supporting Statement B	Uploaded 2010-11-09	Repair queued
Attachment J -- Response to McNeil Comments.doc	Supplementary Document	Uploaded 2010-11-09	Repair queued
Attachment I - Comments from McNeil Consumer Healthcare.pdf	Supplementary Document	Uploaded 2010-11-09	Repair queued
Attachment G - Recruitment Letter and Post Card.pdf	Supplementary Document	Uploaded 2010-11-09	Repair queued
Attachment A -- Healthcare Research and Quality Act of 1999.pdf	Supplementary Document	Uploaded 2010-11-09	Repair queued
Supporting Statement Part A -- Understanding Patients' Knowledge and Use of Acetaminophen phase2 9-22-2010.doc	Supporting Statement A	Uploaded 2010-11-09	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
195412	Telephone Screener	Form and Instruction	New
195411	Surveys with Adults (greater than 65 years)	Form and Instruction	New
195410	Surveys with Adults (20 to 65 years)	Form and Instruction	New
195409	Surveys with Adolescents(13 to 20 years of age)	Form and Instruction	New
195408	Surveys with Parents of children	Form and Instruction	New

ICR Details

OMB Control No:	ICR Reference No: 201011-0935-002
Status: Historical Inactive	Previous ICR Reference No:
Agency/Subagency: HHS/AHRQ	Agency Tracking No:
Title: Understanding Patients Knowledge and Use of Acetaminophen Phase 2
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Withdrawn	Conclusion Date: 03/24/2011
	Date Received in OIRA: 11/23/2010
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date		12 Months From Approved
Responses	0	0	0
Time Burden (Hours)	0	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: This proposed data collection is a cross-sectional prospective survey to identify issues that relate to the misuse and overdosing of over-the-counter (OTC) acetaminophen. The survey was developed based on results from a previous data collection (OMB control number 0935-0154, approved on 10/13/2009). Acetaminophen is the most widely used analgesic and antipyretic drug in the U.S. When appropriately used, it is a very safe agent. However, a single large overdose, or several supratherapeutic dosages in a short period of time, has been associated with acute liver failure, which can occur with dosages over 250 mg/kg over a 24-hour period, or > 12 g in an adult. Toxicity from acetaminophen has been on the rise in the past 3 decades, and is now the most common cause of acute liver failure in the U.S., surpassing viral hepatitis. This project has the following aims: 1)To estimate frequency of use, knowledge, and practices regarding use of OTC acetaminophen, and 2)Evaluate potential determinants of misuse in community-based samples.

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Authorizing Statute(s): US Code: 42 USC 299 Name of Law: Healthcare Research and Quality Act of 1999
  

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:
	75 FR 52951	08/30/2010
30-day Notice:	Federal Register Citation:	Citation Date:
	75 FR 67372	11/02/2010
Did the Agency receive public comments on this ICR? Yes

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

table that charts list of burden

IC Title	Form No.	Form Name
Surveys with Parents of children <= 8 years of age	Form #1	Questionnaire for parents of children
Surveys with Adolescents(13 to 20 years of age)	Form #2	Questionnaire for adolescents
Surveys with Adults (20 to 65 years)	Form #3	Questionnaire for adults 21 to 65
Surveys with Adults (greater than 65 years)	Form #4	Questionnaire for adults gt 65
Telephone Screener	Form #5	Telephone screener

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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 request for a new information collection.

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Annual Cost to Federal Government: $280,269

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

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: 11/23/2010

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