2010-21498. 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 [e-mail]. 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, [phone], or by e-mail at [e-mail].

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

Data collection mode	Number of respondents	Number of responses per respondent	Hours per response	Total burden hours
Surveys with Parents of Children < 8 years of age	300	1	30/60	150
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
Total	800	na	na	400

EXHIBIT 2—Estimated Annualized Cost Burden

Data collection mode	Number of respondents	Total burden hours	Average hourly wage rate*	Total cost burden
Surveys with Parents of Children < 8 years of age	300	150	$20.90	$3,135
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

Cost component	Total 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.