Document headings vary by document type but may contain
                    the following: the agency or agencies that issued and signed a document
the number of the CFR title and the number of each part
                      the document amends, proposes to amend, or is directly
                      related to
the agency docket number / agency internal file number
the RIN which identifies each regulatory action listed in
                      the Unified Agenda of Federal Regulatory and Deregulatory
                      Actions See the
                    Document Drafting Handbook
                    for more details.
 Department of Health and Human Services Agency for Healthcare Research and Quality
 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. 35013520, AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the 
                        **Federal Register**
                         on August 30th 2010 and allowed 60 days for public comment. No comments were received. The purpose of this notice is to allow an additional 30 days for public comment.
 DATES: Comments on this notice must be received by December 2, 2010.
 ADDRESSES: Written comments should be submitted to: AHRQ's OMB Desk Officer by fax at (202) 395-6974 (attention: AHRQ's desk officer) or by e-mail at 
                        *OIRA_submission@omb.eop.gov*
                         (attention: AHRQs desk officer). 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—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) 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 years of age). 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. (5) Telephone screener. The telephone screener will be used to recruit a subset of respondents for which a contact telephone number is available. 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 
                    ( print page 67373)
                    to complete. The telephone screener will be used with a subset of 500 potential respondents, 300 of which are expected to screen-in. The telephone screener takes about 2 minutes to complete. The total annualized burden for all participants is estimated to be 417 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 $8,716. Exhibit 1—Estimated Annualized Burden Hours
Data collection mode
Number of 
                             respondents
Number of 
                             responses per respondent
Hours per 
                             response
Total burden hoursSurveys with Parents of children < 8 years of age
300
1
30/60
150Surveys with Adolescents (13 to 20 years of age)
200
1
30/60
100Surveys with Adults (20 to 65 years)
150
1
30/60
75Surveys with Adults (greater than 65 years)
150
1
30/60
75Telephone Screener
500
1
2/60
17Total
1,300
na
na
417
 Exhibit 2—Estimated Annualized Cost Burden
Data collection mode
Number of 
                             respondents
Total burden hours
Average hourly wage rate
Total cost 
                             burdenSurveys with Parents of children < 8 years of age
300
150
$20.90
$3,135Surveys with Adolescents (13 to 20 years of age)
200
100
20.90
2,090Surveys with Adults (20 to 65 years)
150
75
20.90
1,568Surveys with Adults (greater than 65 years)
150
75
20.90
1,568Telephone Screener
500
17
20.90
355Total
1,300
417
na
8,716* 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 costProject Development
$33,590Data Collection Activities
85,760Data Processing and Analysis.
30,800Publication of Results
750Project Management
31,093Overhead
98,276Total
280,269
 Request for Comments In accordance with the above-cited Paperwork Reduction Act legislation, comments on AHRQs 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: October 19, 2010. Carolyn M. Clancy, Director.


[FR Doc. 2010-27566 Filed 11-1-10; 8:45 am] BILLING CODE 4160-90-M