Federal Register / Vol. 72, No. 96 / Friday, May 18, 2007 / Notices 28053 

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. 

This proposed information collection 

was previously published in the Federal 

Register on December 1, 2006 and 

allowed 60 days for public comment. 

The purpose of this notice is to 

publish prior comments received and 

agency responses as well as allow an 

additional 30 days for public comment. 

Public comments were received and 

are included at the end of this notice, 

along with responses to the comments. 

DATES: Comments on this notice must be 

received by June 18, 2007. 

ADDRESSES: Written comments should 

be submitted to: Karen Matsuoka by fax 

at (202) 395–6974 (attention: AHRQ’s 

desk office) or by e-mail at 

OIRA_submission@omb.eop.gov 

(attention: AHRQ’s desk officer). 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 Privacy and Security 

regulations of the Health Insurance 

Protection and Portability Act, 45 CFR 

Parts 160, 162 and 164 and with 45 CFR 

part 46, the ‘‘Common rule’’ regarding 

the Conduct of Research Involving 

Human Subjects. An informed consent 

with 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, health service 

use, health status, adverse drug events, 

satisfaction with the MTMP, and 

demographics. Study pharmacists will 

assess subject’s medication use, the 

appropriateness of each prescribed 

medication using a validated scale, and 

will provide information about their 

own satisfactions 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. 

299 c–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 

of the study 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, 

data 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 Chat Review and Abstraction.400 ......................... 2 1 800 


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28054 Federal Register / Vol. 72, No. 96 / Friday, May 18, 2007 / Notices 

Respondents and response type Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per response (hours) 

Total burden 

(hours) 

Study Investigators and Personnel/Preparing Electronic Pharmacy 

Records.

4 (from 4 different 

sites).

2 4 32 

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

** Refers to time on the part of investigators and study personnel in obtaining informed consent from subjects. 

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 

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 

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. 

Comments on the 60 Day Notice Federal 

Register Notice 

Comment a: Study design favors self 

selection of patients who are mobile, 

able to accurately self-report data 

elements and have sufficient cognitive 

function and health status to benefit 

from patient education and participate 

for the study duration. How then will 

this study design inform about how to 

intervene for the oldest and sickest 

beneficiaries? 

Response: Clearly no single study can 

address all patient populations that 

might benefit from medication therapy 

management (MTM). In order for this 

study to be both practical and 

generalizable to the broadest range of 

Medicare beneficiaries, we have targeted 

those that are mobile, able to accurately 

self-report the required data elements 

and have sufficient cognitive function 

and health status to benefit from the 

intervention and participate for the 

study duration. Nevertheless, we 

recognize that certain patients may be at 

higher risk than others. Therefore, the 

protocol has been revised to focus on 

those beneficiaries at greater risk of drug 

related problems (DRPs) and adverse 

drug events (ADEs)—and thus 

presumably in the greatest need for 

medication therapy management 

(MTM). Entry criteria in the revised 

protocol include (1). must be least 65 

years old as of August 1, 2007; (2). must 

have 3 or more comorbid conditions 

associated with increased healthcare 

utilization (conditions include diabetes 

mellitus, heart failure, asthma, 

hypertension, dyslipidemia, COPD, 

coronary artery disease, chronic renal 

failure, arthritis, depression, dementia, 

chronic pain, and conditions requiring 

anticoagulation); (3). must have visited 

a physician at one or more of the clinics 

on a regular basis (defined as 2 or more 

clinic visits over 1 year prior to the 

study start) for these condition; (4). 

must have received 8 or more different 

chronic prescription medications over 

the 6 months prior to the enrollment 

period; (5) must have a telephone line 

and agree to maintain it for at least 6 

months; and (6). must have one of the 

following situations placing him/her at 

risk for a DRP: (a) ER visit in past 30 

days, (b) new physician in past 30 days, 

(c) hospitalization in past 30 days, (d) 

change in mediation in past 30 days, or 

(e) 3 or more providers. 

Comment b: Although five specific 

services are identified, they are not 

standardized. Lack of a standardized 

intervention means that it will be 

impossible to draw valid comparisons 

between the control and intervention 

groups. 

Response: The intervention has been 

revised to focus on medication 

reconciliation and DRP assessment. The 

intervention will be well-defined, with 

specific tools or ‘‘aids’’ for 

implementation, and it will be 

standardized across the study sites. A 

‘‘toolkit’’ will be produced that will 

allow the intervention to be reproduced 

once the study is completed. 

Comment c: The identified 

interventions do not address the most 

critical element of MTM—assessment of 

the appropriateness of medications, 

including identification of untreated 

indications that would be followed by 

recommendations to prescribers. In the 

proposed study, while pharmacists will 

be addressing continuity of care, the 

assumption appears to be that the initial 

prescription choice is always 

appropriate. We believe this is a major 

weakness of the study protocol. 

Response: Assessment of untreated 

indications is clearly one type of DRP 

that will be assessed as part of this 

study. Follow-up recommendations will 

be provided to prescribers. 

Comment d: Of the five interventions 

identified in the study protocol, several 

fall outside the purview of a 

pharmacist’s traditional training such as 

scheduling follow-up doctor’s 

appointments, obtaining transportation 

to the clinic or motivating patients to 

take their medications using 

motivational interviewing techniques. 

We are concerned about the feasibility 

and cost of training pharmacists to 

undertake these tasks. 

Response: The purpose for this study 

is to assess components of MTM. 

Providers of MTM may include 

pharmacists or other healthcare 

professionals. Thus, a ‘‘pharmacist’s 

traditional training’’ is not necessarily 

relevant to the design of the 

intervention. Nevertheless, as 

mentioned above, the intervention has 

been revised to focus on medication 

reconciliation and DAP assessment—

two activities which are likely within 

the purview of most pharmacists. 

Comment e: What is the method of 

that will be used to achieve an equal or 

roughly proportional number of 

enrollees in each group? 

Response: Stratified randomization. 

Comment f: Similarly, how is the site 

effect controlled for, particularly since a 

disproportionate number of subjects 

may be enrolled at the University of 

Illinois at Chicago site (100 patients)? 

Response: There will be an equal 

number of subjects enrolled at each site. 

Comment g: How will be the 

investigators account for failure to 

enroll beneficiaries in either group? 

Response: Each study site draws from 

a large pool of eligible participants and 

includes experienced investigators who 

have successfully recruited patients for 

similar types of studies. Given the 

relatively low burden for participation, 

the study is anticipated to enroll an 


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Federal Register / Vol. 72, No. 96 / Friday, May 18, 2007 / Notices 28055 

adequate sample. However, should the 

initial recruitment efforts be 

unsuccessful we will intensify efforts by 

contacting physicians to refer patients, 

posting advertisements, and screening 

patients seen in applicable clinics. Also, 

if failure to enroll at one site is a 

problem we can increase enrollment at 

other sites to compensate. 

Comment h: Presumably, participants 

in the control group will be receiving 

some level of MTM by virtue of Part D 

enrollment. How will ‘‘usual care’’, 

which could contain widely variable 

applications of MTM, be defined, 

measured, controlled, and distinguished 

from the ‘‘intervention’’? 

Response: Patients already enrolled in 

an MTM program where medication 

reconciliation and/or assessment of 

DRPs has occurred in the previous 12 

months will be excluded. 

Comment i: What methodology will 

be employed to control for potential 

confounders residing with the 

pharmacist; for example, pharmacist 

tenure/experience with MTM service? 

Response: There will be a small 

number of pharmacists at each site (1 or 

2) and all of the pharmacists will be of 

similar tenure/experience. Training will 

be provided to all pharmacists so that 

the protocol is implemented in a 

standard manner. 

Comment j: How will non-adherence 

to scheduled monthly MTM program 

visits and subsequent missing data be 

accounted for? Will this be a lastobservation-carried-forward study? Will 

beneficiaries who do not keep 

appointments for some percentage of 

their scheduled follow-up visits be 

excluded or treated as controls? Is there 

a procedure for identifying why patients 

leave the study? 

Response: The intervention has been 

changed from monthly visits to just 2 

visits. With this reduced number of 

visits we do not anticipate significant 

non-compliance. An intent-to-treat 

analysis will be conducted, meaning 

that the analysis will be based on the 

group to which subjects were originally/ 

randomly assigned. 

Comment k: Will pharmacists 

evaluate all of the beneficiary’s 

medications or just those that are Part D 

covered? Presumably, one would 

assume the former; however, this should 

be explicitly stated. And again, how 

does this differ from ‘‘usual care’’? 

Likewise, how will non-Part D 

medications, particularly samples and 

OTC medications, be accounted for 

regarding medication adherence (patient 

self-report, pharmacy claims, both)? 

Response: The program will evaluate 

all medications. Medication adherence 

has been removed as an outcome 

measure for the study. 

Comment l: It seems unlikely that 

when assessed for 12-month recall of 

adverse events at the close of the study, 

participants will be able to relate an 

accurate history. A participant log or 

dairy might support recall of events. 

Response: The protocol has been 

changed and we will now assess this at 

day 90 and 180 for only the preceding 

3 months, using a structured interview. 

In order to assist with recall, we will 

provide participants with a patient log 

or diary to record drug related problems. 

Comment m: We believe that the 

investigators may have underestimated 

the time required to collect information 

from study participants and to abstract 

data from clinical records, particularly 

given the number of tools and 

measurements that will be employed. 

Additionally, there appears to be no 

formal training of pharmacists in the 

utilization and application of these 

instruments, which may further 

underestimate burden. 

Response: Significant changes have 

now been made to reduce the patient 

and investigator time. A formal training 

session will be held for pharmacists 

who will provide the intervention and 

tools have been developed to 

standardize the intervention as 

mentioned above. 

Comment n: As we have 

communicated in the list of questions/ 

concerns about design (above), we 

believe that the study could be 

strengthened by clearer definitions of 

the intervention ‘‘MTM program’’ and 

the ‘‘dose’’ (that is, the specific type and 

amount of services that the treating 

pharmacist elects to provide a given 

beneficiary). If doses are not standard 

across beneficiaries, as one would 

expect, what characteristics/criteria will 

be used to determine dose? 

Response: The revised protocol may 

contain more data upon which to assess 

these issues. The intervention has been 

more clearly defined and narrowed in 

scope, and the number of visits has been 

reduced. 

Comment o: The study could be 

strengthened by explication of 

techniques for accrual, randomization, 

and follow up on missed appointments 

and handling of missing data. 

Response: All of these items are 

included in the revised protocol. 

Comment p: While we strongly favor 

and actively use electronic clinical 

records for MTM, we have found that 

automated data collection techniques 

(such as interactive voice response, or 

IVR) are frequently impractical for 

collecting data from older adults who 

may have difficulty hearing, need more 

time to respond than is typically 

programmed, and need to have items 

repeated. However, data collection via 

telephone with a ‘‘live’’ data collector 

and web-enabled medication 

management devices that also track 

adherence and present questions/collect 

information from patients are 

potentially very useful in terms of data 

accuracy and completeness. One 

caution exists in terms of interpretation 

and generalizability of the findings: 

Automated data collection techniques 

might ‘‘cue’’ the beneficiary in a way 

that inflates the effect; as such, cues 

would presumably not be present in 

standard (non-experimental) application 

of MTM programs. This could lead to 

inflation of effect and potential Type 1 

error. Studies are needed that explore 

the feasibility and utility of automated 

data collection with older adults who 

are at risk for medication-related 

problems and poor outcomes. 

Response: This study uses no 

automated collection techniques. 

Comment q: ACCP recommends that 

inclusion of additional survey questions 

that would investigate the process by 

which beneficiaries are being informed 

and educated about the availability of 

MTMPs for eligible enrollees, and how 

the plans are promoting MTMPs among 

their enrollees. 

Response: The purpose of the 

proposed study is to evaluate a specific 

MTM intervention. While important 

questions, a survey of MTM providers 

about the process by which beneficiaries 

are being informed and educated about 

the availability of MTMPs for eligible 

enrollees, and how the plans are 

promoting MTMPs among their 

enrollees is not within the scope of the 

study. 

Comment r: We strongly believe that 

any research in the area of MTMP will 

be very helpful in determining the effect 

of these programs, but it appears in the 

proposed project that community 

pharmacy sites are being excluded from 

the study. Community pharmacy must 

be represented in any study evaluating 

the effectiveness of MTMP, so as to 

determine potential strengths and/or 

barriers to providing these programs in 

the community pharmacy setting. We 

question the broad applicability of this 

research project based on the sites from 

which study subjects will be recruited 

and we strongly encourage the 

involvement of community pharmacy 

practice sites in this project. 

Response: AHRQ recognizes the 

importance of community pharmacy as 

one site in which MTM may be 

provided. No study can be designed to 

include all aspects of diversity in the 

site of provision of MTM. For this study 


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28056 Federal Register / Vol. 72, No. 96 / Friday, May 18, 2007 / Notices 

we attempted to obtain a balance 

between availability of data needed to 

assess the impact of the intervention, 

and the generalizability of the setting of 

care. In revisions made to the protocol 

we have focused on developing an 

intervention that could be conducted in 

a community pharmacy, and as such 

may be generalizable to community 

pharmacies. 

Dated: May 10, 2007. 

Carolyn M. Clancy, 

Director. 

[FR Doc. 07–2481 Filed 5–17–07; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–10233, CMS–

10234 and CMS–10236] 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

AGENCY: Centers for Medicare & 

Medicaid Services, HHS. 

In compliance with the requirement 

of section 3506(c)(2)(A) of the 

Paperwork Reduction Act of 1995, the 

Centers for Medicare & Medicaid 

Services (CMS) is publishing the 

following summary of proposed 

collections for public comment. 

Interested persons are invited to send 

comments regarding this burden 

estimate or any other aspect of this 

collection of information, including any 

of the following subjects: (1) The 

necessity and utility of the proposed 

information collection for the proper 

performance of the agency’s functions; 

(2) the accuracy of the estimated 

burden; (3) ways to enhance the quality, 

utility, and clarity of the information to 

be collected; and (4) the use of 

automated collection techniques or 

other forms of information technology to 

minimize the information collection 

burden. 

1. Type of Information Collection 

Request: New collection; Title of 

Information Collection: Regional 

Preferred Provider Organization (RPPO) 

Reconciliation Cost Report; Form 

Number: CMS–10233 (OMB#: 0938–

New); Use: The Medicare Prescription 

Drug, Improvement, and Modernization 

Act of 2003 (MMA), Title II, Subtitle C 

(Offering of Medicare Advantage 

Regional Plans; Medicare Advantage 

Competition) provided for the 

establishment of Medicare Advantage 

Regional Plans. Subsequently, the 

Regional Preferred Provider 

Organization (RPPO) program was 

developed and began contracting with 

Managed Care Organizations (MCOs) 

and enrolling beneficiaries for the 2006 

contract year. Section 1858 of the Social 

Security Act provides for risk sharing 

with RPPOs to be in place for contract 

years 2006 and 2007. The Code of 

Federal Regulations at 42 CFR 422.458 

provides specific direction with respect 

to how the Centers for Medicare and 

Medicaid Services (CMS) will share risk 

with the RPPOs. The regulations require 

CMS to collect Allowable Cost data, and 

to compare this data to Target Amounts. 

If the comparison demonstrates that 

there were either savings or losses in the 

contract year, the regulations provide 

specific risk corridors to be used in 

determining the Risk Sharing 

Reconciliation amount due to either the 

plan or CMS. The Risk Sharing 

Reconciliation cost report will be used 

to collect the information necessary to 

accurately reconcile the payments made 

to RPPOs for the 2006 and 2007 contract 

years. Frequency: Reporting—Annually; 

Affected Public: Business or other forprofit and Not-for-profit institutions; 

Number of Respondents: 14; Total 

Annual Responses: 14; Total Annual 

Hours: 1,120. 

2. Type of Information Collection 

Request: New collection; Title of 

Information Collection: State Plan Preprint implementing Section 6087 of the 

Deficit Reduction Act: Optional SelfDirection Personal Assistance Services 

(PAS) Program (Cash and Counseling); 

Form Number: CMS–10234 (OMB#: 

0938–New); Use: Information submitted 

via the State Plan Amendment (SPA) 

pre-print will be used by the Centers for 

Medicare & Medicaid Services (CMS) 

Central and Regional Offices to analyze 

a State’s proposal to implement Section 

6087 of the Deficit Reduction Act 

(DRA). State Medicaid Agencies will 

complete the SPA pre-print, and submit 

it to CMS for a comprehensive analysis. 

The pre-print contains assurances, 

check-off items, and areas for States to 

describe policies and procedures for 

subjects such as quality assurance, risk 

management, and voluntary and 

involuntary disenrollment; Frequency: 

Reporting—Once; Affected Public: State, 

Local, or Tribal Government; Number of 

Respondents: 56; Total Annual 

Responses: 30; Total Annual Hours: 600. 

3. Type of Information Collection 

Request: New collection; Title of 

Information Collection: Disclosure of 

Financial Relationships Report 

(‘‘DFRR’’); Form Number: CMS–10236 

(OMB#: 0938–New); Use: Section 

1877(f) of the Social Security Act 

requires that each entity providing 

covered items or services for which 

payment may be made shall provide the 

Secretary with information concerning 

the entity’s ownership, investment, and 

compensation arrangements, in such 

form, manner, and at such times as the 

Secretary shall specify. DFRR is a new 

collection instrument that will be used 

by CMS to obtain information necessary 

to analyze each hospital’s compliance 

with Section 1877 of the Social Security 

Act (‘‘the physician self-referral law’’), 

and implementing regulations (42 Code 

of Federal Regulations, Subpart J). 

Frequency: Reporting—Once; Affected 

Public: Business or other for-profit and 

Not-for-profit institutions; Number of 

Respondents: 500; Total Annual 

Responses: 500; Total Annual Hours: 

2,000. 

To obtain copies of the supporting 

statement and any related forms for the 

proposed paperwork collections 

referenced above, access CMS’ Web Site 

address at http://www.cms.hhs.gov/ 

PaperworkReductionActof1995, or email your request, including your 

address, phone number, OMB number, 

and CMS document identifier, to 

Paperwork@cms.hhs.gov, or call the 

Reports Clearance Office on (410) 786–

1326. 

To be assured consideration, 

comments and recommendations for the 

proposed information collections must 

be received at the address below, no 

later than 5 p.m. on July 17, 2007. 

CMS, Office of Strategic Operations 

and Regulatory Affairs, Division of 

Regulations Development—B, Attention: 

William N. Parham, III, Room C4–26–

05, 7500 Security Boulevard, Baltimore, 

Maryland 21244–1850. 

Dated: May 11, 2007. 

Michelle Shortt, 

Director, Regulations Development Group, 

Office of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. E7–9472 Filed 5–17–07; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–265–94 and 

CMS–460] 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

AGENCY: Centers for Medicare & 

Medicaid Services, HHS. 

In compliance with the requirement 

of section 3506(c)(2)(A) of the 

Paperwork Reduction Act of 1995, the 


pwalker on PROD1PC71 with NOTICES