Federal Register / Vol. 71, No. 231 / Friday, December 1, 2006 / Notices 69567 

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, Department of Health and 

Human Services. 

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) allow the proposed 

information collection project: 

‘‘Evaluation of a Medication Therapy 

Management Program to Improve 

Patient Safety in Medicare 

Beneficiaries.’’ 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. 

DATES: Comments on this notice must be 

received by January 30, 2007. 

ADDRESSES: Written comments should 

be submitted to: Doris Lefkowitz, 

Reports Clearance Officer, AHRQ, 540 

Gaither Road, Room #5036, Rockville, 

MD 20850. 

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 

‘‘Evaluation of a Medication Therapy 

Management Program (MTMP) To 

Improve Patient Safety in Medicare 

Beneficiaries’’

The Medicare Modernization Act of 

2003 (MMA) requires Medicare 

prescription drug plans to have a MTMP 

that is developed in cooperation with 

licensed and practicing pharmacists and 

physicians for targeted beneficiaries. 

MTMP is defined in the MMA as a 

program of drug therapy management 

that is designed to assure, with respect 

to targeted beneficiaries, that covered 

part D drugs are appropriately used to 

optimize therapeutic outcomes through 

improved medication use, and to reduce 

the risk of adverse events, including 

adverse drug interactions. 

The proposed MTMP research project 

will prospectively evaluate the effects of 

a specific drug therapy management 

program on health outcomes and patient 

safety in a group of research subjects 

aged 65 or older, living with multiple 

chronic health conditions and taking 

multiple part D medications. The 

evaluation will be designed as a 

randomized, controlled study with 

subjects recruited from multiple 

ambulatory care or family practice 

medical clinics in the States of Illinois, 

North Carolina, and Texas. The study 

will be coordinated by clinical 

scientists, physicians, and pharmacists 

affiliated with AHRQ, Baylor Health 

Care System, Duke University, RTI 

International, and the University of 

Illinois at Chicago. 

The study protocol and data 

collection procedures for the MTMP 

research evaluation will be reviewed by 

the official Institutional Review Boards 

at each participating study site. The 

study will be conducted in accordance 

with the rules and regulations of the 

Health Insurance Protection and 

Portability Act and with the ‘‘Guidelines 

for the Conduct of Research Involving 

Human Subjects.’’ An informed consent 

will be obtained (see Table below) prior 

to subject enrollment in the study. For 

individuals who consent to participate, 

confidential identifiable information 

will be collected as described in the 

informed consent document. Subjects 

will be asked to provide information 

about medication use, adherence to 

prescription instructions, health 

services use, health status, adverse drug 

events, satisfaction with the MTMP, and 

demographics. Study pharmacists will 

assess subjects’ medication use, the 

appropriateness of each prescribed 

medication using a validated scale, and 

will provide information about their 

own satisfaction with the MTMP. All 

study information will be entered and 

maintained in a secure, passwordprotected database and will be protected 

in accordance with AHRQ’s 

confidentiality statute, Section 934(c) of 

the Public Health Service Act (42 U.S.C. 

299c–3(c)). 

Methods of Collection 

The data will be collected using 

several methods at study entry and at 

the end of the study. Questionnaire data 

will be obtained via direct patient 

interview by clinical investigators who 

will record the information on a paper 

form. In addition, a self-administered 

paper patient survey will be collected 

during scheduled patient study visits in 

both the intervention and control arms 

to assess the effects of participation in 

the medication therapy management 

program. All survey forms will be 

entered and maintained in a secure, 

password-protected database. Patient 

health, medication history, and 

hospitalization information will be 

obtained through a review of the 

subjects’ electronic or paper medical 

records. Information on prescriptions 

filled (e.g., number of tablets, directions, 

date filled) and refill frequency will be 

obtained through electronic pharmacy 

records, when these records are 

available and when access is authorized 

by the subject. 

Estimated Annual Respondent Burden 

The Table below indicates the total 

time burden required to obtain all of the 

data required to meet the study’s 

objectives. The Table does not include 

time required to analyze the data and 

prepare it for statistical reporting, 

analysis and publication. 

Respondents and response type Number of 

respondents 

Number of 

responses per 

respondent 

Average burden 

per response 

(hours) 

Total burden 

(hours) 

Study Participants/Informed Consent ............................................... 400 .................. 1 0 .25 100 

Study Participants/Patient Survey .................................................... 400 .................. 2 0 .75 600 

Study Investigators and Personnel/Informed Consent ..................... 400 .................. 1 0 .25 100 

Study Investigators and Personnel/Patient Survey .......................... 400 .................. 2 0 .75 600 

Study Investigators and Personnel/Medical Chart Review and Abstraction.400 .................. 2 1 800 

Study Investigators and Personnel/Preparing Electronic Pharmacy 

Records.

4 (from 4 different sites).2 4 32 

Total ........................................................................................... ......................... ............................ .............................. 2232 


rmajette on PROD1PC67 with NOTICES1
69568 Federal Register / Vol. 71, No. 231 / Friday, December 1, 2006 / Notices 

Estimated Costs to the Federal 

Government 

The cost estimate to the federal 

government is $1,400,000. 

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: November 20, 2006. 

Carolyn M. Clancy, 

Director. 

[FR Doc. 06–9485 Filed 11–30–06; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Notice of Meeting 

In accordance with section 10(d) of 

the Federal Advisory Committee Act (5 

U.S.C., Appendix 2), announcement is 

made of a Health Care Policy and 

Research Special Emphasis Panel (SEP) 

meeting. 

A Special Emphasis Panel is a group 

of experts in fields related to health care 

research who are invited by the Agency 

for Healthcare Research and Quality 

(AHRQ), and agree to be available, to 

conduct on an as needed basis, 

scientific reviews of applications for 

AHRQ support. Individual members of 

the Panel do not attend regularly 

scheduled meetings and do not serve for 

fixed terms or a long period of time. 

Rather, they are asked to participate in 

particular review meetings which 

require their type of expertise. 

Substantial segments of the upcoming 

SEP meeting listed below will be closed 

to the public in accordance with the 

Federal Advisory Committee Act, 

section 10(d) of 5 U.S.C., Appendix 2 

and 5 U.S.C. 552b(c)(6). Grant 

applications for the Announcement of 

Availability of Funds for Grants 

regarding Adolescent Family Life (AFL) 

Research are to be reviewed and 

discussed at this meeting. This program 

is sponsored by the Office of Population 

Affairs. These discussions are likely to 

reveal personal information concerning 

individuals associated with the 

applications. This information is 

exempt from mandatory disclosure 

under the above-cited statutes. 

SEP Meeting on: Announcement of 

Availability of Funds for Grants 

regarding Adolescent Family Life (AFL) 

Research. 

Date: December 11, 2006 (Open on 

December 11 from 8:30 a.m. to 8:45 a.m. 

and closed for the remainder of the 

meeting). 

Place: John M. Eisenberg Building, 

AHRQ Conference Center, 540 Gaither 

Road, Rockville, Maryland 20850. 

Contact Person: Anyone wishing to 

obtain a roster of members, agenda or 

minutes of the non-confidential portions 

of this meeting should contact Mrs. 

Bonnie Campbell, Committee 

Management Officer, Office of 

Extramural Research, Education and 

Priority Populations, AHRQ, 540 

Gaither Road, Room 2038, Rockville, 

Maryland 20850, Telephone (301) 427–

1554. 

Agenda items for this meeting are 

subject to change as priorities dictate. 

Dated: November 20, 2006. 

Carolyn M. Clancy, 

Director. 

[FR Doc. 06–9486 Filed 11–30–06; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Proposed Information Collection 

Activity; Comment Request 

Proposed Projects 

Title: Itemized Undistributed 

Collections (Schedule UDC). 

OMB No.: 0970–0268. 

Description: State agencies 

administering the Child Support 

Enforcement Program under Title IV–D 

of the Social Security Act are required 

to provide information each fiscal 

quarter to the Office of Child Support 

Enforcement (OCSE) concerning 

administrative expenditures and the 

receipt and disposition of child support 

payments from non-custodial parents 

(Forms OCSE–396A and OCSE–34A—

OMB NO. 0970–0181). Together with a 

third quarterly report, ‘‘Itemized 

Undistributed Collections,’’ these forms 

provide information from each State 

that is used to compute the quarterly 

grant awards, the annual incentive 

payments and provide valuable 

information on program finances. This 

information is also included in a 

published annual statistical and 

financial report, available to the general 

public. 

Public Law 109–171, the Deficit 

Reduction Act of 2005, contains a 

number of provisions that will impact 

the States’ completion and submission 

of these quarterly financial reports. 

These changes become effective in fiscal 

years 2006, 2007 and 2008. These 

changes require revisions to some of the 

data entry lines and reporting 

instructions currently contained on 

these forms. In addition, a periodic 

review of the data currently requested 

on these forms will assure that OCSE 

collects the information needed in the 

most efficient format feasible. 

Respondents: State agencies 

administering the Child Support 

Enforcement Program. 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average burden 

hours per 

response 

Total burden 

hours 

Schedule UDC ................................................................................................. 54 4 4 864 


rmajette on PROD1PC67 with NOTICES1