Understanding Patient's Knowledge and Use of Acetaminophen

Forms and Documents

Document Name	Status
Form Form #7 Semi-structured interviews with Pharmacists Form	New
Form Form #6 Semi-structured Interview with Primary care physicians Form	New
Form Form #5 Semi-structured interviews with Adolescents(13 to 20 years of age) Form	New
Form Form #4 Focus group with Adults Form	New
Form Form #3 Focus group with Parents of children ≤ 8 years of age Form	New
Form Form #2 Self-administered questionnaire Form	New
Form Form #1 Screening form Form	New
tylenol icr.doc Supplementary Document	2009-09-23
Attachment D1 -- Post Participation Education.pdf Supplementary Document	2009-09-23
Attachment K -- Consent Forms.pdf Supplementary Document	2009-09-23
Attachment L--Adolescent.Demographics.pdf Supplementary Document	2009-09-23
Attachment M.pdf Supplementary Document	2009-09-23
Attachment J -- Actions Taken in Response to Comments.doc Supplementary Document	2009-05-11
Attachment I -- Comments.pdf Supplementary Document	2009-05-11
Attachment H -- 60 Day FR Notice.pdf Supplementary Document	2009-05-11
Attachment A -- Healthcare Research and Quality Act of 1999.pdf Supplementary Document	2009-05-11
Attachment F1 -- Physician and Pharmacist Recruit letter.doc Supplementary Document	2009-05-11
Attachment F1 -- Physician and Pharmacist Recruit letter.doc Supplementary Document	2009-05-11
Attachment E1 -- Adolescent Recruit Letter.doc Supplementary Document	2009-05-11
Attachment D1 -- How to Read an OTC Drug Label .doc Supplementary Document	2009-05-11
Attachment D1 -- How to Read an OTC Drug Label .doc Supplementary Document	2009-05-11
Supporting Statement Part A -- Understanding Patients Knowledge and Use of Acetaminophen 5-8-2009.doc Supporting Statement A	2009-05-11

IC Document Collections

IC ID	Document Title	Status
189145	Semi-structured interviews with Pharmacists Form	New
189144	Semi-structured Interview with Primary care physicians Form	New
189143	Semi-structured interviews with Adolescents(13 to 20 years of age) Form	New
189142	Focus group with Adults Form	New
189141	Focus group with Parents of children ≤ 8 years of age Form	New
189140	Self-administered questionnaire Form	New
189139	Screening form Form	New

ICR Details

OMB Control No: 0935-0154	ICR Reference No: 200905-0935-002
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/AHRQ	Agency Tracking No:
Title: Understanding Patient's Knowledge and Use of Acetaminophen
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: Approved with change	Conclusion Date: 10/13/2009
	Date Received in OIRA: 05/13/2009
Terms of Clearance: This ICR is approved consistent with revised supporting statement, revised instruments, and AHRQ memo of September 4, 2009 and July 13, 2009. Given the small size of this focus group study and its qualitative/exploratory nature, AHRQ agrees that caution should used in interpreting the study results and drawing any causal inferences from them. Should AHRQ publish or otherwise disclose the results of this study, AHRQ will disclose all study limitations, including threats to its internal and external validity. The approval is also on the understanding that this focus group study is one part of a larger study. Specifically, the results from this focus group study are intended to inform the development of a draft survey instrument which AHRQ anticipates subjecting to additional focus group and pilot testing. AHRQ may submit the request for that additional focus group and pilot testing under AHRQ’s generic pretesting clearance, with final approval contingent on the extent to which the generic clearance is appropriate for that request. Lastly, AHRQ agrees to submit a full clearance request for the final larger study, which all of this focus group and pilot testing will inform. When AHRQ submits the request for further focus groups/pilot testing and for the final larger study, AHRQ should provide a report on the results from the prior studies that informed them (e.g. the supporting statement for the draft survey instrument should explain clearly how the results of this focus group fed into the instrument, while the supporting statement for the final larger study should explain clearly how the results of the further focus groups/pilot tests have informed it). AHRQ is reminded that all materials respondents will be seeing as part of studies—e.g. recruitment letters, consent forms, etc. -- should be included as part of ICR submissions in order to be considered complete.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2010	12 Months From Approved
Responses	332	0	0
Time Burden (Hours)	134	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: This proposed data collection is a qualitative study to preliminarily identify issues that relate to the misuse and overdosing of over-the-counter (OTC) acetaminophen. 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. Because this study is exploratory, the data collection will employ convenience samples of individuals from different segments of the population. Parents of young children, adolescents, adults and health providers will be included. Populations that have not been previously evaluated in the U.S. including ethnic minorities and older adults will be recruited. The results of this qualitative phase will provide an understanding of the issues of relevance and will be used to develop a comprehensive survey.

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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:
	74 FR 8798	02/26/2009
30-day Notice:	Federal Register Citation:	Citation Date:
	74 FR 20951	05/06/2009
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 7

IC Title	Form No.	Form Name
Screening form	Form #1	Screening form
Self-administered questionnaire	Form #2	Self-administered Questionnaire
Focus group with Parents of children ≤ 8 years of age	Form #3	Focus Group Guide for Parent's of children
Focus group with Adults	Form #4	Focus group guide for Adults
Semi-structured interviews with Adolescents(13 to 20 years of age)	Form #5	Semi-structured interviews with Adolescents
Semi-structured Interview with Primary care physicians	Form #6	Semi-structured Interview with Primary care physicians
Semi-structured interviews with Pharmacists	Form #7	Semi-structured interviews with Physicians and Pharmacists

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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	332	0	0	332	0	0
Annual Time Burden (Hours)	134	0	0	134	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 request is for a new information collection.

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Annual Cost to Federal Government: $164,440

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: 05/13/2009

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