Agency Information Collection Activities: Proposed Collection; Comment Request, 35485-35487 [07-3159]

Download as PDF Federal Register / Vol. 72, No. 124 / Thursday, June 28, 2007 / Notices http://www.hhs.gov/healthit/ahic/ population/pop_instruct.html. DEPARTMENT OF HEALTH AND HUMAN SERVICES Dated: June 20, 2007. Judith Sparrow, Director, American Health Information Community, Office of Programs and Coordination, Office of the National Coordinator for Health Information Technology. [FR Doc. 07–3170 Filed 6–27–07; 8:45 am] Office of the National Coordinator for Health Information Technology; American Health Information Community Consumer Empowerment Workgroup Meeting ACTION: BILLING CODE 4150–24–M DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the National Coordinator for Health Information Technology; American Health Information Community Quality Workgroup Meeting ACTION: Announcement of meeting. SUMMARY: This notice announces the 10th meeting of the American Health Information Community Quality Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92–463, 5 U.S.C., App.). July 18, 2007, from 1 p.m. to 4 p.m. [Eastern]. DATES: Mary C. Switzer Building (330 C Street, SW., Washington, DC 20201), Conference Room 4090 (please bring photo ID for entry to a Federal building). ADDRESSES: FOR FURTHER INFORMATION CONTACT: http://www.hhs.gov/healthit/ahic/ quality/. The Workgroup will continue its discussion on how health information technology can provide the data needed for the development of quality measures that are useful to patients and others in the health care industry, automate the measurement and reporting of a comprehensive current and future set of quality measures, and accelerate the use of clinical decision support that can improve performance on those quality measures. The meeting will be available via Web cast. For additional information, go to: http://www.hhs.gov/healthit/ahic/ quality/quality_instruct.html. mstockstill on PROD1PC66 with NOTICES SUPPLEMENTARY INFORMATION: Dated: June 20, 2007. Judith Sparrow, Director, American Health Information Community, Office of Programs and Coordination, Office of the National Coordinator for Health Information Technology. [FR Doc. 07–3171 Filed 6–27–07; 8:45 am] BILLING CODE 4150–24–M VerDate Aug<31>2005 18:23 Jun 27, 2007 Jkt 211001 Announcement of meeting. SUMMARY: This notice announces the 18th meeting of the American Health Information Community Consumer Empowerment Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92–463, 5 U.S.C., App.). DATES: July 11, 2007, from 1 p.m. to 4 p.m. [Eastern]. ADDRESSES: Mary C. Switzer Building (330 C Street, SW., Washington, DC 20201), Conference Room 4090. Please bring photo ID for entry to a Federal building. FOR FURTHER INFORMATION CONTACT: http://www.hhs.gov/healthit/ahic/ consumer/. SUPPLEMENTARY INFORMATION: The Workgroup will continue its discussion on how to encourage the widespread adoption of a personal health record that is easy-to-use, portable, longitudinal, affordable, and consumercentered. The meeting will be available via Web cast. For additional information, go to: http://www.hhs.gov/healthit/ahic/ consumer/ce_instruct.html. Dated: June 20, 2007. Judith Sparrow, Director, American Health Information Community, Office of Programs and Coordination, Office of the National Coordinator for Health Information Technology. [FR Doc. 07–3172 Filed 6–27–07; 8:45 am] BILLING CODE 4150–24–M DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the National Coordinator for Health Information Technology; American Health Information Community Electronic Health Records Workgroup Meeting ACTION: Announcement of meeting. SUMMARY: This notice announces the 17th meeting of the American Health Information Community Electronic Health Records Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92–463, 5 U.S.C., App.). PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 35485 July 10, 2007, from 1 p.m. to 4 p.m. [Eastern]. ADDRESSES: Mary C. Switzer Building (330 C Street, SW., Washington, DC 20201), Conference Room 4090. Please bring photo ID for entry to a Federal building. DATES: FOR FURTHER INFORMATION CONTACT: http://www.hhs.gov/healthit/ahic/ healthrecords/. SUPPLEMENTARY INFORMATION: The Workgroup will continue its discussion on ways to achieve widespread adoption of certified EHRs, minimizing gaps in adoption among providers. The meeting will be available via Web cast. For additional information, go to: http://www.hhs.gov/healthit/ahic/ heatlhrecords/ehr_instruct.html. Dated: June 20, 2007. Judith Sparrow, Director, American Health Information Community, Office of Programs and Coordination, Office of the National Coordinator for Health Information Technology. [FR Doc. 07–3173 Filed 6–27–07; 8:45 am] BILLING CODE 4150–24–M DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality Agency Information Collection Activities: Proposed Collection; Comment Request Agency for Health Care Research and Quality, Department of Health and Human Services. ACTION: Notice. AGENCY: SUMMARY: This notice announces the intention of the Agency for Healthcare and Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) allow the proposed information collection project: ‘‘Development of an Electronic System for Reporting Medication Errors and Adverse Drug Events in Primary Care Practice (MEADERS).’’ In accordance with the Paperwork Reduction Act of 1995, Public Law 104–13 (44 U.S.C. 3506(c)(2)(A)), AHRQ invites the public to comment on this proposed information collection. An earlier version of this proposed information collection notice was previously published in the Federal Register and a period of 90 days was allowed for public comment. At the request of OMB, AHRQ is publishing this notice to allow an additional 30 days for public comment. The original E:\FR\FM\28JNN1.SGM 28JNN1 35486 Federal Register / Vol. 72, No. 124 / Thursday, June 28, 2007 / Notices 30 day notice is available at http:// a257.g.akamaitech.net/7/257/2422/ 01jan20071800/edocket.access.gpo.gov/ 2007/pdf/07-574.pdf . DATES: Comments on this notice must be received by July 30, 2007. ADDRESSES: Written comments should be submitted to: Doris Lefkowitz, Reports Clearance Officer, AHRQ, 540 Gaither Road, Room #5036, Rockville, MD 20850, or 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 AHRQ’s Reports Clearance Officer. FOR FURTHER INFORMATION CONTACT: Doris Lefkowitz, AHRQ, Reports Clearance Officer, (301) 427–1477. SUPPLEMENTARY INFORMATION: Proposed Project mstockstill on PROD1PC66 with NOTICES ‘‘Development of an Electronic system for Reporting Medication Errors and Adverse Drug Events in Primary Care Practice (MEADERS)’’ AHRQ will develop and pilot test an electronic system for reporting medication errors and adverse drug events that occur in outpatient physician practices. The reporting system, MEADERS, is being developed in collaboration with the Food and Drug Administration (FDA) and data collected will closely mirror information included in paper-based physician reports to MedWatch. While the major purpose of this project is to determine the ability and willingness of busy clinicians to use the electronic reporting system and to investigate barriers and facilitators to its actual use in practice, the data collected on medication errors and adverse drug events will be reported back to practices for their use in improving the quality of care provided. The landmark Harvard Medical Practice Study, published in 1991, stated that 98,000 Americans die each year from medical errors. (Ref: Brennan TA, Leape LL, Laird NM, et al. Incidence of Adverse events and negligence in hospitalized patients: Results of the Harvard Medical Practice Study. N Engl J Med 1991; 324:370– 376.) Although the exact figure has been disputed, no one disputes the fact that too many Americans are injured unnecessarily by medical mistakes that could be avoided. (Ref: McDonald CJ, Weiner J, Hui SL. Deaths due to medical errors are exaggerated in the Institute of Medicine Report. JAMA. 2000; 284:93– 95 and Leape LL. Institute of Medicine medical error figures are not VerDate Aug<31>2005 18:23 Jun 27, 2007 Jkt 211001 exaggerated. JAMA. 2000; 28:95–97). Another study performed by the Department of Veterans Affairs suggests that in one out of every 10,000 hospitalizations, a patient dies due directly to a medical error. (Ref: Hayward RA, Hofer TP. Estimating hospital deaths due to medical errors: Preventability is in the eye of the reviewer. JAMA. 2001; 286:415–420). In response to the growing concern over medical errors, the Agency for Healthcare Research and Quality (AHRQ) has published three important monographs outlining the problem of errors, (Ref: Institute of Medicine. To Err Is Human: Building a Safer Health System. Washington, DC: National Academy Press, 2000), their effects on the quality of care, (Ref: Institute of Medicine. Crossing the Quality Chasm: A New System for the 21st Century. Washington, DC: National Academy Press, 2001), and offering suggestions on improving patient safety. (Ref: Institute of Medicine. Patient Safety: Achieving a New Standard for Care. Washington, DC: National Academy Press, 2004). The first recommendation of this third monograph was to ‘‘capture information on patient safety—including both adverse events and near misses—as a byproduct of care, and use this information to design even safer care delivery systems.’’ One central theme to each of these monographs is that there simply is too much chaotic information flowing in the medical environment for a single provider to handle effectively. Therefore, solutions to the problem of medical errors should include some combination of health information technology and redesign of health care systems to enhance the prevalence of appropriate decisons (i.e., avoiding errors of omission) and reduce the occurrence of avoidable mistakes (i.e., avoiding errors of commission). A recent conference sponsored by AHRQ highlighted interventions to improve medical decision-making and reduce medical errors. (Ref: http:// www.blsmeetings.net/ PatientSafetyandHIT/ (Accessed August 11, 2005)). Most of the interventions presented were based in hospitals, where the most intensive and immediately life-threatening events occur. Yet the majority of medical decisions are made in outpatient practices and offices where there has been little error-reduction research performed. Further, most outpatient studies have been performed in academic medical centers which have capabilities, providers, and patients that may not typify the average U.S. medical practice. (Ref: Green LA, Fryer GE, Yawn BP, Lanier D, Dovey SM: The PO 00000 Frm 00065 Fmt 4703 Sfmt 4703 ecology of medical care revisited. N Engl J Med 2001; 344:2021–2025). With the recent passing of the Patient Safety and Quality Improvement Act of 2005, 42 U.S.C. 299b–21–b–26, now is an opportune time to evaluate a primary care error reporting system. In most primary care practices there is no mechanism in place to report medication errors as they occur, and adverse drug events observed in the primary care setting are currently underreported to the FDA. (Ref: Uribe CL, Schweikhart SB, Pathak DS, Dow M, Marsh GB. Perceived barriers to medical-error reporting: An exploratory investigation. J Healthcare Management. 2002;47(4):263–79). We propose to develop and pilot test a computer-based error reporting system to better understand the ability of physicians to identify their own medication errors as well as adverse drug events, and their willingness to report them electronically. The fundamental objectives are to (1) evaluate the usefulness, ease of use, and actual use of the system in everyday clinical practices, and (2) identify provider and practice characteristics that predict uptake and use of this system in participating primary care practices. The data collected on medication errors and adverse drug events will be aggregated by practice and fed back to the practice for its use in improving the quailty of care provided. Methods of Collection A total of 45 physicians and their practice staff will participate in the pilot test of the reporting system in addition to completing baseline surveys of their practice and reporting on use and satisfaction with the reporting system. The reporting system will request information about the patient involved (to be encrypted), category of event (error, adverse drug event, drug-drug interaction), timing of event, specific medications involved, type of event (e.g., wrong drug prescribed, wrong dose, wrong patient), contributing factors, and evidence of patient harm. The surveys will capture data describing the practice and the patients it serves, the extent of the error reporting system’s use, and an assessment of the users’ overall satisfaction with the system. Practice and provider information will be collected at baseline along with characteristics that could be facilitators (such as an electronic medical record system) or barriers (such as lack of time and resources needed to report information) to implementation of the MEADERS system. Data collected on the system’s use will include the number of clinicians who have used MEADERS at E:\FR\FM\28JNN1.SGM 28JNN1 35487 Federal Register / Vol. 72, No. 124 / Thursday, June 28, 2007 / Notices least once, the number of times used overall, the time it takes to enter data into the electronic MEADERS, and the types of medication errors and adverse drug events that are being reported. A follow-up assessment will include clinicians’ and managers’ satisfaction with the system (e.g., ease of use, usefulness of the generated reports and individual feedback) and whether they intend to continue its use after the study period has concluded. Although any clinician in the practice will be able to use the system, physicians are likely to be the primary users of the system. We estimate that physicians will account for about 80% of MEADERS use and Nurse Practitioners, Physician Assistants and Medical Assistants will make up the remainder (see Exhibit 1). The time for entering an event into the system is estimated to require no more than 8 minutes of a clinician’s time. Estimated Annual Respondent Burden EXHIBIT 1.—ESTIMATE OF COST BURDEN TO RESPONDENTS Number of responses * Data collection effort Estimated time per respondent in hours Estimated total burden hours Average hourly wage rate ** Estimated annual cost burden to respondents Office Manager Baseline survey ...................................... Physician baseline survey ............................................... Physician opinion survey of system ................................ Physician entry of medication error ................................. Nurse opinion survey of system ...................................... Nurse entry of medication error ....................................... PA/NP opinion survey of system ..................................... PA/NP entry of medication error ...................................... Medical assistant survey of system ................................. Medical assistant entry of medication error ..................... Office Manager opinion-survey of system ....................... 45 45 45 216 45 18 45 18 45 18 45 0.25 0.25 0.25 0.134 0.25 0.134 0.25 0.134 0.25 0.134 0.25 11.25 11.25 11.25 28.94 11.25 2.4 11.25 2.4 11.25 2.4 11.25 $34.67 57.90 57.90 57.90 27.35 27.35 34.17 34.17 12.58 12.58 34.67 $390.04 651.38 651.38 1675.63 307.69 65.64 384.41 82.00 141.53 30.19 390.04 Total .......................................................................... 585 .......................... 114.89 ........................ 4769.93 * Based on a six month trial period of MEADER reporting system. ** Based upon the mean of the average wages, National Compensation Survey: Occupation wages in the United States 2004, ‘‘U.S. Department of Labor, Bureau of Labor Statistics.’’ This information collection will not impose a cost burden on the respondent beyond that associated with their time to provide the required data. There will be no additional costs for capital equipment, software, computer services, etc. Comments submitted in response to this notice will be summarized and included in the request for OMB approval of the proposed information collection. All comments will become a matter of public record. Estimated Costs to the Federal Government The total cost to the government for this activity is estimated to be $640,000.00. Dated: June 21, 2007. Carolyn M. Clancy, Director. [FR Doc. 07–3159 Filed 6–27–07; 8:45 am] BILLING CODE 4160-90-M mstockstill on PROD1PC66 with NOTICES Request for Comments In accordance with the above-cited 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 health care research and information dissemination functions of AHRQ, 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. VerDate Aug<31>2005 18:23 Jun 27, 2007 Jkt 211001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality Agency Information Collection Activities: Proposed Collection; Comment Request Agency for Healthcare Research and Quality, HHS. ACTION: Notice. AGENCY: This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request the Office of Management and Budget (OMB) to allow the proposed information collection project: 2008– 2009 Medical Expenditure Panel Survey—Insurance Component (MEPS– IC). In accordance with the Paperwork SUMMARY: PO 00000 Frm 00066 Fmt 4703 Sfmt 4703 Reduction Act of 1995, Pub. L. 104–13 (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 August 27, 2007. ADDRESSES: Written comments should be submitted to: William Carroll, Reports Clearance Officer, AHRQ, 540 Gaither Road, Room 5048, Rockville, MD 20850. 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. SUPPLEMENTARY INFORMATION: Proposed Project 2008 and 2009 Medical Expenditure Panel Survey—Insurance Component (MEPS–IC). The MEPS–IC, an annual survey of the characteristics of employersponsored health insurance, was first conducted by AHRQ in 1997 for the calendar year 1996. The survey has since been conducted annually for calendar years 1997 through 2006. AHRQ proposes to continue this annual survey of establishments for calendar years 2008 and 2009. The survey data E:\FR\FM\28JNN1.SGM 28JNN1

Agencies

[Federal Register Volume 72, Number 124 (Thursday, June 28, 2007)]
[Notices]
[Pages 35485-35487]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 07-3159]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


Agency Information Collection Activities: Proposed Collection; 
Comment Request

AGENCY: Agency for Health Care Research and Quality, Department of 
Health and Human Services.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: This notice announces the intention of the Agency for 
Healthcare and Research and Quality (AHRQ) to request that the Office 
of Management and Budget (OMB) allow the proposed information 
collection project: ``Development of an Electronic System for Reporting 
Medication Errors and Adverse Drug Events in Primary Care Practice 
(MEADERS).'' In accordance with the Paperwork Reduction Act of 1995, 
Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)), AHRQ invites the public to 
comment on this proposed information collection.
    An earlier version of this proposed information collection notice 
was previously published in the Federal Register and a period of 90 
days was allowed for public comment. At the request of OMB, AHRQ is 
publishing this notice to allow an additional 30 days for public 
comment. The original

[[Page 35486]]

30 day notice is available at http://a257.g.akamaitech.net/7/257/2422/
01jan20071800/edocket.access.gpo.gov/2007/pdf/07-574.pdf .

DATES: Comments on this notice must be received by July 30, 2007.

ADDRESSES: Written comments should be submitted to: Doris Lefkowitz, 
Reports Clearance Officer, AHRQ, 540 Gaither Road, Room 5036, 
Rockville, MD 20850, or 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 AHRQ's Reports Clearance Officer.

FOR FURTHER INFORMATION CONTACT: Doris Lefkowitz, AHRQ, Reports 
Clearance Officer, (301) 427-1477.

SUPPLEMENTARY INFORMATION:

Proposed Project

``Development of an Electronic system for Reporting Medication Errors 
and Adverse Drug Events in Primary Care Practice (MEADERS)''

    AHRQ will develop and pilot test an electronic system for reporting 
medication errors and adverse drug events that occur in outpatient 
physician practices. The reporting system, MEADERS, is being developed 
in collaboration with the Food and Drug Administration (FDA) and data 
collected will closely mirror information included in paper-based 
physician reports to MedWatch. While the major purpose of this project 
is to determine the ability and willingness of busy clinicians to use 
the electronic reporting system and to investigate barriers and 
facilitators to its actual use in practice, the data collected on 
medication errors and adverse drug events will be reported back to 
practices for their use in improving the quality of care provided. The 
landmark Harvard Medical Practice Study, published in 1991, stated that 
98,000 Americans die each year from medical errors. (Ref: Brennan TA, 
Leape LL, Laird NM, et al. Incidence of Adverse events and negligence 
in hospitalized patients: Results of the Harvard Medical Practice 
Study. N Engl J Med 1991; 324:370-376.)
    Although the exact figure has been disputed, no one disputes the 
fact that too many Americans are injured unnecessarily by medical 
mistakes that could be avoided. (Ref: McDonald CJ, Weiner J, Hui SL. 
Deaths due to medical errors are exaggerated in the Institute of 
Medicine Report. JAMA. 2000; 284:93-95 and Leape LL. Institute of 
Medicine medical error figures are not exaggerated. JAMA. 2000; 28:95-
97). Another study performed by the Department of Veterans Affairs 
suggests that in one out of every 10,000 hospitalizations, a patient 
dies due directly to a medical error. (Ref: Hayward RA, Hofer TP. 
Estimating hospital deaths due to medical errors: Preventability is in 
the eye of the reviewer. JAMA. 2001; 286:415-420).
    In response to the growing concern over medical errors, the Agency 
for Healthcare Research and Quality (AHRQ) has published three 
important monographs outlining the problem of errors, (Ref: Institute 
of Medicine. To Err Is Human: Building a Safer Health System. 
Washington, DC: National Academy Press, 2000), their effects on the 
quality of care, (Ref: Institute of Medicine. Crossing the Quality 
Chasm: A New System for the 21st Century. Washington, DC: National 
Academy Press, 2001), and offering suggestions on improving patient 
safety. (Ref: Institute of Medicine. Patient Safety: Achieving a New 
Standard for Care. Washington, DC: National Academy Press, 2004). The 
first recommendation of this third monograph was to ``capture 
information on patient safety--including both adverse events and near 
misses--as a byproduct of care, and use this information to design even 
safer care delivery systems.'' One central theme to each of these 
monographs is that there simply is too much chaotic information flowing 
in the medical environment for a single provider to handle effectively. 
Therefore, solutions to the problem of medical errors should include 
some combination of health information technology and redesign of 
health care systems to enhance the prevalence of appropriate decisons 
(i.e., avoiding errors of omission) and reduce the occurrence of 
avoidable mistakes (i.e., avoiding errors of commission).
    A recent conference sponsored by AHRQ highlighted interventions to 
improve medical decision-making and reduce medical errors. (Ref: http:/
/www.blsmeetings.net/PatientSafetyandHIT/ (Accessed August 11, 2005)). 
Most of the interventions presented were based in hospitals, where the 
most intensive and immediately life-threatening events occur. Yet the 
majority of medical decisions are made in outpatient practices and 
offices where there has been little error-reduction research performed. 
Further, most outpatient studies have been performed in academic 
medical centers which have capabilities, providers, and patients that 
may not typify the average U.S. medical practice. (Ref: Green LA, Fryer 
GE, Yawn BP, Lanier D, Dovey SM: The ecology of medical care revisited. 
N Engl J Med 2001; 344:2021-2025).
    With the recent passing of the Patient Safety and Quality 
Improvement Act of 2005, 42 U.S.C. 299b-21-b-26, now is an opportune 
time to evaluate a primary care error reporting system. In most primary 
care practices there is no mechanism in place to report medication 
errors as they occur, and adverse drug events observed in the primary 
care setting are currently under-reported to the FDA. (Ref: Uribe CL, 
Schweikhart SB, Pathak DS, Dow M, Marsh GB. Perceived barriers to 
medical-error reporting: An exploratory investigation. J Healthcare 
Management. 2002;47(4):263-79). We propose to develop and pilot test a 
computer-based error reporting system to better understand the ability 
of physicians to identify their own medication errors as well as 
adverse drug events, and their willingness to report them 
electronically. The fundamental objectives are to (1) evaluate the 
usefulness, ease of use, and actual use of the system in everyday 
clinical practices, and (2) identify provider and practice 
characteristics that predict uptake and use of this system in 
participating primary care practices. The data collected on medication 
errors and adverse drug events will be aggregated by practice and fed 
back to the practice for its use in improving the quailty of care 
provided.

Methods of Collection

    A total of 45 physicians and their practice staff will participate 
in the pilot test of the reporting system in addition to completing 
baseline surveys of their practice and reporting on use and 
satisfaction with the reporting system. The reporting system will 
request information about the patient involved (to be encrypted), 
category of event (error, adverse drug event, drug-drug interaction), 
timing of event, specific medications involved, type of event (e.g., 
wrong drug prescribed, wrong dose, wrong patient), contributing 
factors, and evidence of patient harm. The surveys will capture data 
describing the practice and the patients it serves, the extent of the 
error reporting system's use, and an assessment of the users' overall 
satisfaction with the system. Practice and provider information will be 
collected at baseline along with characteristics that could be 
facilitators (such as an electronic medical record system) or barriers 
(such as lack of time and resources needed to report information) to 
implementation of the MEADERS system. Data collected on the system's 
use will include the number of clinicians who have used MEADERS at

[[Page 35487]]

least once, the number of times used overall, the time it takes to 
enter data into the electronic MEADERS, and the types of medication 
errors and adverse drug events that are being reported. A follow-up 
assessment will include clinicians' and managers' satisfaction with the 
system (e.g., ease of use, usefulness of the generated reports and 
individual feedback) and whether they intend to continue its use after 
the study period has concluded.
    Although any clinician in the practice will be able to use the 
system, physicians are likely to be the primary users of the system. We 
estimate that physicians will account for about 80% of MEADERS use and 
Nurse Practitioners, Physician Assistants and Medical Assistants will 
make up the remainder (see Exhibit 1). The time for entering an event 
into the system is estimated to require no more than 8 minutes of a 
clinician's time.

Estimated Annual Respondent Burden

                               Exhibit 1.--Estimate of Cost Burden to Respondents
----------------------------------------------------------------------------------------------------------------
                                                     Estimated                                       Estimated
                                     Number of       time per        Estimated        Average       annual cost
     Data collection effort         responses *   respondent  in   total burden     hourly wage      burden to
                                                       hours           hours          rate **       respondents
----------------------------------------------------------------------------------------------------------------
Office Manager Baseline survey..              45           0.25            11.25          $34.67         $390.04
Physician baseline survey.......              45           0.25            11.25           57.90          651.38
Physician opinion survey of                   45           0.25            11.25           57.90          651.38
 system.........................
Physician entry of medication                216           0.134           28.94           57.90         1675.63
 error..........................
Nurse opinion survey of system..              45           0.25            11.25           27.35          307.69
Nurse entry of medication error.              18           0.134            2.4            27.35           65.64
PA/NP opinion survey of system..              45           0.25            11.25           34.17          384.41
PA/NP entry of medication error.              18           0.134            2.4            34.17           82.00
Medical assistant survey of                   45           0.25            11.25           12.58          141.53
 system.........................
Medical assistant entry of                    18           0.134            2.4            12.58           30.19
 medication error...............
Office Manager opinion-survey of              45           0.25            11.25           34.67          390.04
 system.........................
                                 ----------------                ----------------                ---------------
    Total.......................             585  ..............          114.89  ..............         4769.93
----------------------------------------------------------------------------------------------------------------
* Based on a six month trial period of MEADER reporting system.
** Based upon the mean of the average wages, National Compensation Survey: Occupation wages in the United States
  2004, ``U.S. Department of Labor, Bureau of Labor Statistics.''

    This information collection will not impose a cost burden on the 
respondent beyond that associated with their time to provide the 
required data. There will be no additional costs for capital equipment, 
software, computer services, etc.

Estimated Costs to the Federal Government

    The total cost to the government for this activity is estimated to 
be $640,000.00.

Request for Comments

    In accordance with the above-cited 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 health care research and 
information dissemination functions of AHRQ, 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 request for OMB approval of the proposed 
information collection. All comments will become a matter of public 
record.

    Dated: June 21, 2007.
Carolyn M. Clancy,
Director.
[FR Doc. 07-3159 Filed 6-27-07; 8:45 am]
BILLING CODE 4160-90-M