[Federal Register: February 26, 2009 (Volume 74, Number 37)]
[Notices]
[Page 8798-8799]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26fe09-58]
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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
doris.lefkowitz@ahrq.hhs.gov.
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
doris.lefkowitz@ahrq.hhs.gov.
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............................
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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
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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