[Federal Register Volume 75, Number 167 (Monday, August 30, 2010)]
[Notices]
[Pages 52951-52952]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-21498]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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. 
3501-3520, AHRQ invites the public to comment on this proposed 
information collection.

DATES: Comments on this notice must be received by October 29, 2010.

ADDRESSES: Written comments should be submitted to: Doris Lefkowitz, 
Reports Clearance Officer, AHRQ, by e-mail at 
[email protected]. 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) To 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). 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.
    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 to complete. The total annualized burden for 
all participants is estimated to be 400 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 $8,361.

                                  Exhibit 1--Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                     Number of
              Data collection mode                   Number of     responses per     Hours per     Total burden
                                                    respondents     respondent       response          hours
----------------------------------------------------------------------------------------------------------------
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
                                                 ---------------------------------------------------------------

[[Page 52952]]

 
    Total.......................................             800              na              na             400
----------------------------------------------------------------------------------------------------------------


                                   EXHIBIT 2--Estimated Annualized Cost Burden
----------------------------------------------------------------------------------------------------------------
                                                     Number of     Total burden   Average hourly    Total cost
              Data collection mode                  respondents        hours        wage rate*        burden
----------------------------------------------------------------------------------------------------------------
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
                                                 ---------------------------------------------------------------
    Total.......................................             800             400              na           8,361
----------------------------------------------------------------------------------------------------------------
* 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
------------------------------------------------------------------------
                                                                  Total
                        Cost component                            cost
------------------------------------------------------------------------
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
                                                               ---------
    Total.....................................................   280,269
------------------------------------------------------------------------

Request for Comments

    In accordance with the above-cited Paperwork Reduction Act 
legislation, comments on AHRQ's 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: August 23, 2010.
Carolyn M. Clancy,
Director.
[FR Doc. 2010-21498 Filed 8-27-10; 8:45 am]
BILLING CODE 4160-90-M