Federal Register: May 6, 2009 (Volume 74, Number 86)
DOCID: fr06my09-67 FR Doc E9-10407
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
NOTICE: NOTICES
DOCID: fr06my09-67
DOCUMENT ACTION: Notice.
SUBJECT CATEGORY:
Agency Information Collection Activities: Proposed Collection; Comment Request
DATES: Comments on this notice must be received by June 5, 2009.
DOCUMENT 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.
This proposed information collection was previously published in the Federal Register on February 26th, 2009 and allowed 60 days for public comment. One comment was received. The purpose of this notice is to allow an additional 30 days for public comment.
SUMMARY:
Agency Information Collection Activities; Proposals, Submissions, and Approvals
SUPPLEMENTAL 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 overthecounter (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 selfadministration of OTC acetaminophen, and parental administration of OTC acetaminophen to children. To meet Aim 1 focus groups will be conducted with adults and semistructured interviews will be conducted with adolescents. Aim 2 is to qualitatively explore experiences and practices of key professional informants, including physician and pharmacists, with respect to communicating information on the administration and risks of OTC acetaminophen to consumers and patients. Semistructured 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 IFocus 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.
Semistructured interviews will be conducted with adolescents to
examine selfadministration 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 2SemiStructured 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 audiotaped 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
populations: parents of children [oacute]8 years of age and adults, and
will last about 1\1/2\ hours. Semistructured interviews will be
conducted with 20 adolescents, 20 primary care physicians, and 20 pharmacists and will last 20 to
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30 minutes. The selfadministered questionnaire will be completed by
the focus group participants and the adolescent participants of the
semistructured 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.
Exhibit 1Estimated Annualized Burden Hours
Number of
Data collection mode Number of responses per Hours per Total burden
respondents respondent response hours
Screening form.................................. 124 1 3/60 6
Selfadministered questionnaire................. 84 1 6/60 8
Focus group with parents of children [oacute]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)..................................
Semistructured interviews with adolescents (13 20 1 30/60 10 to 20 years of age)............................
Semistructured interview with primary care 20 1 20/60 7 physicians.....................................
Semistructured interviews with pharmacists..... 20 1 20/60 7
Total....................................... 332 .............. .............. 134
Exhibit 2Estimated Annualized Cost Burden
Number of Total burden Average hourly Total cost
Data collection mode respondents hours wage rate* burden
Screening form.................................. 124 6 $10.30 $62
Selfadministered questionnaire................. 84 8 10.30 82
Focus groups with parents of children [oacute]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)..................................
Semistructured interviews with adolescents (13 20 10 10.30 103 to 20 years of age)............................
Semistructured interviews with primary care 20 7 61.10 428 physicians.....................................
Semistructured interviews with pharmacists..... 20 7 48.22 338
Total....................................... 332 134 .............. 2,001 * 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 sixmonth 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 3Estimated Cost
Cost component Total cost
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 Request for Comments
In accordance with the abovecited 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: April 23, 2009.
Carolyn M. Clancy,
Director.
[FR Doc. E910407 Filed 5509; 8:45 am]
BILLING CODE 416090M
FOR FURTHER INFORMATION CONTACT
Doris Lefkowitz, AHRQ Reports Clearance Officer, (301) 4271477, or by email at
doris.lefkowitz@ahrq.hhs.gov.