[Federal Register Volume 74, Number 37 (Thursday, February 26, 2009)]
[Notices]
[Pages 8798-8799]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-3959]


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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.'' In accordance with the Paperwork Reduction Act of 
1995, 44 U.S.C. 3506(c)(2)(A), AHRQ invites the public to comment on 
this proposed information collection.

DATES: Comments on this notice must be received by April 27, 2009.

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''

    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. 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 data collection has two aims. Aim 1 is to qualitatively explore 
knowledge, attitudes, beliefs, and practices regarding adult and 
adolescent self-administration of OTC acetaminophen, and parental 
administration of OTC acetaminophen to children. To meet Aim 1, focus 
groups will be conducted with adults and semi-structured interviews 
will be conducted with adolescents. Aim 2 is to qualitatively explore 
experiences and practices of key professional informants, including 
physicians and pharmacists, with respect to communicating information 
on the administration and risks of OTC acetaminophen to consumers and 
patients. Semi-structured interviews will be conducted with target key 
informants. The results of this qualitative study will provide an 
understanding of the relevant issues and will be used to develop a 
comprehensive survey. A second OMB clearance package will be developed 
once the questionnaire for the survey is available.
    This project is being funded by AHRQ pursuant to a cooperative 
agreement with the University of Pennsylvania (Award 1 U18HS017991) as 
part of the Centers for Education and Research on Therapeutics (CERTs) 
program. The CERTs program is a national initiative, administered by 
AHRQ in consultation with the Food and Drug Administration, to increase 
awareness of the benefits and risks of new, existing, or combined uses 
of therapeutics through education and research. See 42 U.S.C. 299b-
1(b).

Method of Collection

Aim 1--Focus groups and individual interviews

    Four focus groups will be conducted with parents of young children 
to examine administration of acetaminophen to children. Four focus 
groups will also be conducted with adults to identify the issues, 
barriers, and psychosocial factors surrounding how, when, and why OTC 
acetaminophen is used. Focus groups will each have 6 to 8 participants. 
Semi-structured interviews will be conducted with adolescents to 
examine self-administration of acetaminophen among this group.
    Content areas to be explored are: a. Knowledge about acetaminophen: 
Brands, terms, combinations, dosage, administration, indications; b. 
beliefs about benefits and risks, including thresholds for toxicity and 
death; c. patterns and frequency of use; d. sources of information 
(e.g., physicians, pharmacists, media); e. related experiences in peers 
(e.g., advice, reports of toxicity); and f. views about labeling, 
packaging and legislation (e.g., restrictions in sales).

Aim 2--Semi-structured interviews with physicians and pharmacists

    Twenty primary care physicians and 20 pharmacists will be 
interviewed. Primary care physicians will be recruited through a 
primary care research network of physicians from both private and 
public clinics. Pharmacists will be recruited at pharmacy facilities 
from hospitals and clinics. Interviews will be conducted over the phone 
or in person, according to the participant's preference, and will last 
approximately 20 minutes. All interviews will be audio-taped and 
transcribed. Participants will be asked about the following: a. 
Frequency and patterns of interaction with consumers and patients with 
respect to acetaminophen; b. types of information provided to 
consumers; c. availability of education materials; and d. views about 
labeling, packaging and legislation.

Estimated Annual Respondent Burden

    Exhibit 1 shows the estimated annualized burden hours for the 
respondents' time to participate in this project. The screening form 
will be completed by all participants and is expected to take 
approximately 3 minutes to complete. Focus groups will include 2 
populations: Parents of children 8 years of age and adults, and will 
last about 1\1/2\ hours. Semi-structured interviews will be conducted 
with 20 adolescents, 20 primary care physicians, and 20 pharmacists and 
will last 20 to 30 minutes. The self-administered questionnaire will be 
completed by the focus group participants and the adolescent 
participants of the semi-structured interviews, and will take about 6 
minutes to complete. The total burden for all participants is estimated 
to be 134 hours.
    Exhibit 2 shows the estimated annualized cost burden for the 
respondent's time to participate in the project. The total cost is 
estimated to be $2,001.

[[Page 8799]]



                                  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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Screening form..........................               124                 1              3/60                 6
Self-administered questionnaire.........                84                 1              6/60                 8
Focus group with parents of children <8                 32                 1               1.5                48
 years of age (4 groups of 8
 participants)..........................
Focus group with adults (4 groups of 8                  32                 1               1.5                48
 participants)..........................
Semi-structured interviews with                         20                 1             30/60                10
 adolescents (13 to 20 years of age)....
Semi-structured interviews with primary                 20                 1             20/60                 7
 care physicians........................
Semi-structured interviews with                         20                 1             20/60                 7
 pharmacists............................
                                         -----------------------------------------------------------------------
    Total...............................               332  ................  ................               134
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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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Screening form..........................               124                 6            $10.30               $62
Self-administered questionnaire.........                84                 8             10.30                82
Focus groups with parents of children <8                32                48             10.30               494
 years of age (4 groups of 8
 participants)..........................
Focus groups with adults (4 groups of 8                 32                48             10.30               494
 participants)..........................
Semi-structured interviews with                         20                10             10.30               103
 adolescents (13 to 20 years of age)....
Semi-structured interviews with primary                 20                 7             61.10               428
 care physicians........................
Semi-structured interviews with                         20                 7             48.22               338
 pharmacists............................
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    Total...............................               332               134  ................             2,001
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* Patient average hourly wage based on the average per capita income of $21,435 (computed into an hourly wage
  rate of $10.30) in Harris County, Texas where the study will take place. Provider hourly wage based on the
  following estimates from National Compensation Survey: Occupational wages in the United States 2006, U.S.
  Department of Labor, Bureau of Labor Statistics: Primary care physician = $61.10/hour; pharmacist = $48.22/
  hour.

Estimates of Annualized Cost to the Government

    Exhibit 3 shows the estimated cost to the Federal Government for 
this six month project.
    The total cost is $164,440. This amount includes all direct and 
indirect costs of the design, data collection, analysis, and reporting 
phase of the study.

                        Exhibit 3--Estimated Cost
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                       Cost component                         Total cost
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Project Development........................................      $13,250
Data Collection Activities.................................       61,699
Data Processing and Analysis...............................       14,080
Publication of Results.....................................          750
Project Management.........................................       17,000
Overhead...................................................       57,661
                                                            ------------
    Total..................................................      164,440
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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 health care research, quality improvement and 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: February 17, 2009.
Carolyn M. Clancy,
Director.
[FR Doc. E9-3959 Filed 2-25-09; 8:45 am]
BILLING CODE 4160-90-M