[Federal Register Volume 75, Number 211 (Tuesday, November 2, 2010)]
[Notices]
[Pages 67372-67373]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-27566]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Agency Information Collection Activities: Proposed Collection;
Comment Request
AGENCY: Agency for Healthcare Research and Quality, HHS.
ACTION: Notice.
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SUMMARY: This notice announces the intention of the Agency for
Healthcare Research and Quality (AHRQ) to request that the Office of
Management and Budget (OMB) approve the proposed information collection
project: ``Understanding Patients' Knowledge and Use of Acetaminophen--
Phase 2.'' In accordance with the Paperwork Reduction Act, 44 U.S.C.
35013520, AHRQ invites the public to comment on this proposed
information collection.
This proposed information collection was previously published in
the Federal Register on August 30th 2010 and allowed 60 days for public
comment. No comments were received. The purpose of this notice is to
allow an additional 30 days for public comment.
DATES: Comments on this notice must be received by December 2, 2010.
ADDRESSES: Written comments should be submitted to: AHRQ's OMB Desk
Officer by fax at (202) 395-6974 (attention: AHRQ's desk officer) or by
e-mail at [email protected] (attention: AHRQs desk officer).
Copies of the proposed collection plans, data collection
instruments, and specific details on the estimated burden can be
obtained from the AHRQ Reports Clearance Officer.
FOR FURTHER INFORMATION CONTACT: Doris Lefkowitz, AHRQ Reports
Clearance Officer, (301) 427-1477, or by e-mail at
[email protected].
SUPPLEMENTARY INFORMATION:
Proposed Project
Understanding Patients' Knowledge and Use of Acetaminophen--Phase 2
AHRQ proposes 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.
This information will be useful for policy makers to consider and
to evaluate regulations and legislation with respect to the
distribution, dispensing and sales of OTC acetaminophen.
This study is being conducted by AHRQ through its contractor, the
University of Texas. This project supports AHRQ's Centers for Education
and Research on Therapeutics initiative to promote the safe and
effective use of therapeutics. See 42 U.S.C. 299b-1(b). It also
supports AHRQ's mandate for the inclusion of priority populations. See
42 U.S.C. 299(c).
Method of Collection
To achieve the projects' aims the following data collections will
be implemented:
(1) Surveys with parents of young children (age < 8 years). The
purpose of this survey is to learn how parents administer acetaminophen
to their children and to identify determinants of misuse of
acetaminophen;
(2) Surveys with adolescents (ages 13 to 20 years of age). The
purpose of this survey is to learn how adolescents use acetaminophen
and to identify determinants of misuse of acetaminophen;
(3) Surveys with adults (21 to 65 years of age). The purpose of
this survey is to learn how adults use acetaminophen and to identify
determinants of misuse of acetaminophen;
(4) Surveys with adults (greater than 65 years of age). The purpose
of this survey is to learn how older adults use acetaminophen and to
identify determinants of misuse of acetaminophen, particularly in
regards to age-related factors.
(5) Telephone screener. The telephone screener will be used to
recruit a subset of respondents for which a contact telephone number is
available.
Data will be collected in-person using paper questionnaires
administered by the project personnel.
Estimated Annual Respondent Burden
Exhibit 1 shows the estimated annualized burden hours for the
respondent's time to participate in this project. Each of the four
questionnaires used in the planned face-to-face surveys will require
approximately 30 minutes
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to complete. The telephone screener will be used with a subset of 500
potential respondents, 300 of which are expected to screen-in. The
telephone screener takes about 2 minutes to complete. The total
annualized burden for all participants is estimated to be 417 hours.
Exhibit 2 shows the estimated annualized cost burden for the
respondent's time to participate in the project. The total annualized
cost burden is estimated to be $8,716.
Exhibit 1--Estimated Annualized Burden Hours
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Number of
Data collection mode Number of responses per Hours per Total burden
respondents respondent response hours
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Surveys with Parents of children < 8 years of 300 1 30/60 150
age............................................
Surveys with Adolescents (13 to 20 years of age) 200 1 30/60 100
Surveys with Adults (20 to 65 years)............ 150 1 30/60 75
Surveys with Adults (greater than 65 years)..... 150 1 30/60 75
Telephone Screener.............................. 500 1 2/60 17
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Total....................................... 1,300 na na 417
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Exhibit 2--Estimated Annualized Cost Burden
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Number of Total burden Average hourly Total cost
Data collection mode respondents hours wage rate burden
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Surveys with Parents of children < 8 years of 300 150 $20.90 $3,135
age............................................
Surveys with Adolescents (13 to 20 years of age) 200 100 20.90 2,090
Surveys with Adults (20 to 65 years)............ 150 75 20.90 1,568
Surveys with Adults (greater than 65 years)..... 150 75 20.90 1,568
Telephone Screener.............................. 500 17 20.90 355
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Total....................................... 1,300 417 na 8,716
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* Based upon the mean of the average wages, National Compensation Survey: Occupational wages in the United
States May 2009, U.S. Department of Labor, Bureau of Labor Statistics.
Estimated Annual Costs to the Federal Government
Exhibit 3 shows the estimated annualized cost to the Federal
government for this six month project. The total cost is $280,269. This
amount includes all direct and indirect costs of the design, data
collection, analysis, and reporting phase of the study.
Exhibit 3--Estimated Annualized Cost
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Cost component Total cost
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Project Development..................................... $33,590
Data Collection Activities.............................. 85,760
Data Processing and Analysis............................ 30,800
Publication of Results.................................. 750
Project Management...................................... 31,093
Overhead................................................ 98,276
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Total............................................... 280,269
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Request for Comments
In accordance with the above-cited Paperwork Reduction Act
legislation, comments on AHRQs information collection are requested
with regard to any of the following: (a) Whether the proposed
collection of information is necessary for the proper performance of
AHRQ healthcare research and healthcare information dissemination
functions, including whether the information will have practical
utility; (b) the accuracy of AHRQ's estimate of burden (including hours
and costs) of the proposed collection(s) of information; (c) ways to
enhance the quality, utility, and clarity of the information to be
collected; and (d) ways to minimize the burden of the collection of
information upon the respondents, including the use of automated
collection techniques or other forms of information technology.
Comments submitted in response to this notice will be summarized
and included in the Agency's subsequent request for OMB approval of the
proposed information collection. All comments will become a matter of
public record.
Dated: October 19, 2010.
Carolyn M. Clancy,
Director.
[FR Doc. 2010-27566 Filed 11-1-10; 8:45 am]
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