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 AHRQs 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
studiese.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
10/31/2010
12 Months From Approved
332
0
0
134
0
0
0
0
0
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.
US Code:
42
USC 299 Name of Law: Healthcare Research and Quality Act of
1999
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:
(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;
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.