46814 Federal Register / Vol. 76, No. 149 / Wednesday, August 3, 2011 / Notices 

even greater (75%). In the absence of an 

effective vaccine, behavioral 

interventions represent one of the few 

methods for reducing high HIV 

incidence among African American 

MSM (AAMSM). Unfortunately, in the 

third decade of the epidemic, very few 

of the available HIV-prevention 

interventions for African American 

populations have been designed 

specifically for MSM. In fact, until very 

recently none of CDC’s evidence-based, 

HIV-prevention interventions had been 

specifically tested for efficacy in 

reducing HIV transmission among MSM 

of color. Given the conspicuous absence 

of (1) Evidence-based HIV interventions 

and (2) outcome evaluations of existing 

AAMSM interventions, our 

collaborative team intends to address a 

glaring research gap by implementing a 

best-practices model of comprehensive 

program evaluation. 

The purpose of this project is to test, 

in a real world setting, the efficacy of an 

HIV transmission prevention 

intervention for reducing sexual risk 

among African American men who have 

sex with men in LAC. The project is a 

3-session, group-level intervention that 

will provide participants with the 

information, motivation, and skills 

necessary to reduce their risk of 

transmitting or acquiring HIV. The 

intervention will be evaluated using 

baseline, 3 month and 6 month followup assessments. This project will also 

conduct in-depth qualitative interviews 

with 36 men in order to assess their 

experiences with the intervention, elicit 

recommendations for improving the 

intervention, and to better understand 

the factors that put African American 

MSM at risk for HIV. 

CDC is requesting a 3-year clearance 

for data collection. The data collection 

system involves screenings, limited 

locator information, contact 

information, a baseline questionnaire, 

client satisfaction surveys, a 3-month 

follow-up questionnaire, a 6-month 

follow-up questionnaire, and case study 

interviews. An estimated 700 men will 

be screened for eligibility in order to 

enroll 528 men. The baseline and follow 

up questionnaires contain questions 

about participants’ socio-demographic 

information, health and healthcare, 

sexual activity, substance use, and other 

psychosocial issues. The duration of 

each baseline, 3-month, and 6-month 

questionnaires are estimated to be 60 

minutes; the 36 Success Case Study 

interviews 90 minutes; Outreach 

Recruitment Assessment 5 minutes; 

limited locator information form 5 

minutes; participant contact information 

form 10 minutes; each client satisfaction 

survey 5 minutes. There is no cost to 

participants other than their time. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondent Form name Number of 

respondents 

Number 

responses per 

espondent 

Average burden 

per respondent 

(in hours) 

Total annual 

urden in hours 

AAMSM ................................ Outreach Recruitment Assessment (screener).700 1 5/60 58 

AAMSM ................................ Limited Locator Information .......... 700 1 5/60 58 

Enrolled AAMSM .................. Participant Contact Information 

Form.

528 1 10/60 88 

Enrolled AAMSM .................. Baseline Questionnaire ................. 528 1 1 528 

Enrolled AAMSM .................. Client Satisfaction Survey ............. 224 3 5/60 56 

Enrolled AAMSM .................. 3 month follow up Questionnaire .. 420 1 1 420 

Enrolled AAMSM .................. 6 month follow up Questionnaire .. 400 1 1 400 

Enrolled AAMSM .................. Success Case Study Interview ..... 36 1 1.5 54 

Total .............................. ....................................................... ............................ ............................ ............................ 1662 

Dated: July 27, 2011. 

Daniel Holcomb, 

Reports Clearance Officer, Centers for Disease 

Control and Prevention. 

[FR Doc. 2011–19614 Filed 8–2–11; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–3143–NC] 

Medicare Program; Evaluation Criteria 

and Standards for Quality 

Improvement Program Contracts 

(10th Statement of Work) 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice with comment period. 

SUMMARY: This notice with comment 

period describes the general criteria we 

intend to use to evaluate the 

effectiveness and efficiency of Quality 

Improvement Organizations (QIOs) that 

will enter into contracts with CMS 

under the 10th Statement of Work 

(SOW) on August 1, 2011. The 

evaluation of a QIOs’ performance 

related to their SOW will be based on 

evaluation criteria specified for the 

aims, drivers, tasks, and subtasks set 

forth in section J–10 of the QIOs’ 10th 

SOW. 

DATES: Effective Date: August 1, 2011 to 

July 31, 2014. 

Comment Date: To be assured 

consideration, comments must be 

received at one of the addresses 

provided below, no later than 5 p.m. on 

September 2, 2011. 

ADDRESSES: In commenting, please refer 

to file code CMS–3143–NC. Because of 

staff and resource limitations, we cannot 

accept comments by facsimile (Fax) 

transmission. 

You may submit comments in one of 

four ways (please choose only one of the 

ways listed): 

1. Electronically. You may submit 

electronic comments on this regulation 

to http://www.regulations.gov. Follow 

the ‘‘Submit a comment’’ instructions. 

2. By regular mail. You may mail 

written comments to the following 

address only: Centers for Medicare & 

Medicaid Services, Department of 

Health and Human Services, Attention: 

CMS–3143–NC, P.O. Box 8010, 

Baltimore, MD 21244–8010. 

Please allow sufficient time for mailed 

comments to be received before the 

close of the comment period. 

3. By express or overnight mail. You 

may send written comments to the 

following address only: Centers for 

Medicare & Medicaid Services, 

Department of Health and Human 

Services, Attention: CMS–3143–NC, 

Mail Stop C4–26–05, 7500 Security 

Boulevard, Baltimore, MD 21244–1850. 


srobinson on DSK4SPTVN1PROD with NOTICES
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4. By hand or courier. Alternatively, 

you may deliver (by hand or courier) 

your written comments only to the 

following addresses prior to the close of 

the comment period: 

a. For delivery in Washington, DC: 

Centers for Medicare & Medicaid 

Services, Department of Health and 

Human Services, Room 445–G, Hubert 

H. Humphrey Building, 200 

Independence Avenue, SW., 

Washington, DC 20201. 

(Because access to the interior of the 

Hubert H. Humphrey Building is not 

readily available to persons without 

Federal government identification, 

commenters are encouraged to leave 

their comments in the CMS drop slots 

located in the main lobby of the 

building. A stamp-in clock is available 

for persons wishing to retain a proof of 

filing by stamping in and retaining an 

extra copy of the comments being filed.) 

b. For delivery in Baltimore, MD: 

Centers for Medicare & Medicaid 

Services, Department of Health and 

Human Services, 7500 Security 

Boulevard, Baltimore, MD 21244–1850. 

If you intend to deliver your 

comments to the Baltimore address, call 

telephone number (410) 786–9994 in 

advance to schedule your arrival with 

one of our staff members. 

Comments erroneously mailed to the 

addresses indicated as appropriate for 

hand or courier delivery may be delayed 

and received after the comment period. 

For information on viewing public 

comments, see the beginning of the 

SUPPLEMENTARY INFORMATION section. 

FOR FURTHER INFORMATION CONTACT: 

Alfreda Staton, 410–786–4194. 

SUPPLEMENTARY INFORMATION: Inspection 

of Public Comments: All comments 

received before the close of the 

comment period are available for 

viewing by the public, including any 

personally identifiable or confidential 

business information that is included in 

a comment. We post all comments 

received before the close of the 

comment period on the following Web 

site as soon as possible after they have 

been received: http:// 

www.regulations.gov. Follow the search 

instructions on that Web site to view 

public comments. 

Comments received timely will also 

be available for public inspection as 

they are received, generally beginning 

approximately 3 weeks after publication 

of a document, at the headquarters of 

the Centers for Medicare & Medicaid 

Services, 7500 Security Boulevard, 

Baltimore, Maryland 21244, Monday 

through Friday of each week from 

8:30 a.m. to 4 p.m. To schedule an 

appointment to view public comments, 

phone 1–800–743–3951. 

I. Background 

Section 1153(h)(2) of the Social 

Security Act (the Act) requires the 

Secretary of the Department of Health 

and Human Services to publish in the 

Federal Register the general criteria and 

standards that will be used to evaluate 

the effective and efficient performance 

of contract obligations by the Quality 

Improvement Organizations (QIOs), and 

to provide the opportunity for public 

comment with respect to these criteria 

and standards. This notice describes the 

general criteria that will be used to 

evaluate QIO performance under the 

10th Statement of Work (SOW) contract 

beginning August 1, 2011. 

II. Provisions of the Notice With 

Comment Period 

Description 

Under the 10th SOW, QIOs are 

responsible for completing the 

requirements for the following Aims: 

Beneficiary and Family Centered Care; 

Improve Individual Care—A Patient 

Safety Aim with components focused on 

Healthcare Associated Infections (HAIs), 

Pressure Ulcers, Physical Restraints, 

Nursing Home Systemic Improvement, 

Adverse Drug Events, Quality Reporting 

and Improvement; Integrate Care for 

Populations and Communities—A Care 

Transitions Aim; and Improve Health 

for Populations and Communities—A 

Prevention Aim. The ability to achieve 

the goals for each Aim will be through 

the following Drivers: Learning and 

Action Networks, Technical Assistance, 

and the Care Reinvention through 

Innovation Spread (CRISP) Model. 

(Detailed information for each Aim and 

Driver may be found in sections C.6. 

through C.10. of the 10th SOW posted 

at the http://www.fedbizopps.gov Web 

site.) 

Beneficiary and Family Centered Care 

(See Section C.6 of the 10th Statement 

of Work) 

The Beneficiary and Family Centered 

Care Aim focuses on: QIO statutorily 

mandated case review activities as well 

as interventions to promote 

responsiveness to beneficiary and 

family needs; providing opportunities 

for listening to and addressing 

beneficiary and family concerns; and 

providing resources for beneficiaries 

and caregivers in decision making. 

Beneficiary-generated concerns provide 

an excellent opportunity to explore root 

causes, develop alternative approaches 

to improving care, and improve 

beneficiary and family experiences with 

the health care system. Beneficiary and 

family engagement and activation efforts 

are needed to produce the best possible 

outcomes of care. These QIO beneficiary 

and family centered efforts align with 

the National Quality Strategy, which 

encourages patient and family 

engagement. 

Improve Individual Patient Care (Patient 

Safety) Initiatives (See Section C.7 of the 

10th Statement of Work) 

The Patient Safety initiatives are 

designed to help achieve the goals of 

improving individual patient care by: 

Reducing Healthcare-Associated 

Infections (HAIs)—Central Line 

Bloodstream Infections (CLABSI), 

Catheter-Associated Urinary Tract 

Infections (CAUTI), Clostridium 

Difficile Infections (CDI) and SurgicalSite Infections (SSI); Reducing 

Healthcare Acquired Conditions in 

Nursing Homes—Pressure Ulcers and 

Physical Restraints; Developing a 

learning and action network to begin to 

make forward progress toward a safer 

system of care; reducing Adverse Drug 

Events (ADEs) and medication-related 

harm; and providing technical 

assistance to hospitals to improve their 

quality of care related to Medicare 

programs such as the Hospital Inpatient 

Quality Reporting (IQR) Program and 

the Hospital Outpatient Quality 

Reporting (OQR) Program to promote 

quality improvement and transparency 

for consumer decision making through 

publicly reported quality data. 

Integrate Care for Populations and 

Communities (See Section C.8 of the 

10th Statement of Work) 

The QIO work must improve the 

quality of care for Medicare 

beneficiaries who transition among care 

settings through a comprehensive 

community effort. These efforts aim to 

reduce readmissions following 

hospitalization and to yield sustainable 

and replicable strategies to achieve 

high-value health care for sick and 

disabled Medicare beneficiaries. 

Improve Health for Populations and 

Communities (See Section C.9 of the 

10th Statement of Work) 

The QIO must improve population 

and community health through 

prevention and early diagnosis by: 

Improving flu immunizations of patients 

ages 50 and older during the flu season; 

improving pneumococcal immunization 

of patients ages 65 and older; improving 

appropriate low-dose aspirin therapy 

use in patients with ischemic vascular 

disease; improving blood pressure 

control in patients with hypertension; 

improving low-density lipoproteincholesterol (LDL–C) control among 

adults with ischemic vascular disease; 

improving tobacco cessation 


srobinson on DSK4SPTVN1PROD with NOTICES
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intervention among adult patients who 

smoke (screening and cessation 

counseling); improving colorectal 

cancer screening in patients ages 50 

through 75; improving breast cancer 

screening in women ages 40 through 69; 

improving participation in the 

Physician Quality Reporting System 

(PQRS); improving the use of Electronic 

Health Records (EHRs) for care 

management; and integrating health 

information technology to achieve 

meaningful use and improve care 

coordination and prevention goals. 

Drivers—Learning and Action Networks, 

Technical Assistance, and Care 

Reinvention Through Innovation Spread 

(CRISP) Model (See Section C.10 of the 

10th Statement of Work) 

Learning and Action Networks are 

mechanisms by which large scale 

improvement around a given aim is 

fostered, studied, adapted, and rapidly 

spread regardless of the change 

methodology, tools, or time-bounded 

initiative that is used to achieve the aim. 

Learning Action Networks collaborate 

with the Regional Extension Centers 

with respect to quality improvement 

and health IT/data related issues. 

Learning and Action Networks 

consciously manage knowledge as a 

valuable resource. They engage leaders 

around an action based agenda. The 

network creates opportunities for indepth learning and problem solving, it 

accepts all offers of support seeking to 

catalyze interested parties, and it is 

transparent, flexible, interchangeable, 

and purposeful. 

It is expected that the QIO will 

develop and facilitate sustainable 

Learning and Action Networks within 

their respective State, as well as 

participate in CMS supported and 

facilitated Learning and Action 

Networks, which will function to 

support QIO activities at the local level. 

The QIO must develop a team(s) 

(number and composition to be 

determined by the QIO) that is 

responsible for supporting and 

facilitating the Learning and Action 

Networks for their respective State. This 

team is responsible for creating interest 

and active participation in the Learning 

and Action Networks from vested 

parties within the State around a 

specific aim(s). 

The QIO must provide technical 

assistance to providers, facilities, and 

partners. The QIO must offer direct 

assistance related to quality 

improvement questions and needs to 

support local providers in making 

changes by connecting the requestor 

with quality improvement knowledge, 

providing follow-up available at the 

local and national level. The QIO must 

rely on their own internal resources, 

those of the community, those availed 

by Federal agencies, and those of the 

National Coordinating Centers. The QIO 

must provide technical assistance to 

individual providers, provider groups or 

health care systems upon their request 

as well as upon the direction of CMS. 

In general, technical assistance is 

more focused, limited, and directed 

than activities of the Learning and 

Action Networks although it could be a 

component of these activities. Some 

activities include the following: 

• The QIO is expected to develop and 

spread a sustainable infrastructure by 

facilitating the adoption of change from 

the QIO to a provider, provider group or 

health care system. 

• The QIO will ensure that each 

initiative includes a sustainability plan 

and the QIO will work to achieve 

consensus among participants so that 

the quality improvement efforts will 

continue as the need continues. 

• The QIO will identify pertinent data 

resources available to support the local 

provider community. This includes 

claims data, data organized by other 

contractors, data available from the 

Centers for Disease Control, National 

Institutes of Health, World Health 

Organization, the Census Bureau, the 

community information available 

through the coordinating center, the 

Center for Medicare and Medicaid 

Innovation, and the Agency for 

Healthcare Research and Quality. The 

QIO must conduct data analysis and 

develop meaningful data reports to be 

used by the local provider community, 

Learning and Action Networks and 

breakthrough initiatives. 

The Care Reinvention through 

Innovation Spread (CRISP) Model is the 

framework for supporting the 

communications and outreach activities 

required to complete all Aims of the 

10th SOW successfully. The CRISP 

Model is designed to minimize internal 

fragmentation, siloing, and duplication 

or conflict of messages across individual 

QIOs and the QIO Program as a whole. 

The Model is used through all activities 

of the 10th SOW so that all QIO 

operations are stakeholder-centric and 

focus on at least one of the three phases 

of communicating with stakeholders 

about quality improvement work: (1) 

Initiation and ‘‘will building’’; (2) 

engagement and maintenance; and (3) 

retention and sustainment throughout 

the life of the QIO task. The goal of the 

model is to give access to the right 

information and services, in the right 

form, at the right time, to the right 

people in the right place. The model 

does this by focusing the QIO’s energies 

such that each policy, action, and 

decision is made with an educated and 

strategic consideration of the impacts 

they may have on stakeholders. 

Under the CRISP Model, the QIO 

must ensure that Innovation Spread 

Advisors (ISAs) are identified for their 

State or territory. This individual(s) 

would bring knowledge to every QIO 

Aim (or project) team within the 

enterprise by: Helping the Aim teams 

determine who the stakeholders are and 

what they need; ensuring beneficiary 

input; facilitating the appropriate 

mechanisms for stakeholder 

communication; and determining if 

activities are successful. The ISA(s) 

from each QIO must attend CMSsponsored training sessions and serve as 

brand ambassadors with branding 

responsibilities as indicated in section 

C.10.3. 

III. Evaluation of the Aims and Drivers 

(See Section J–10 and Section C.5 of the 

10th Statement of Work) 

A qualitative and quantitative 

evaluation will be conducted at the 18th 

(intermediate evaluation) and 27th 

months (final evaluation) of the contract 

with monitoring and measuring for 

improvement conducted throughout the 

3 year contract cycle. The evaluations 

will be based on the most recent data 

available to us. The performance results 

of the evaluation at both time periods 

(that is, 18 months and 27 months) will 

be used, in addition to ongoing 

monitoring activities, to determine the 

performance on the overall contract. 

Using lean and rapid techniques, QIOs 

will be monitored and measured for 

improvement on an ongoing basis using 

self-assessment and Contracting Officer 

Technical Representative (COTR) 

review. The COTR will complete 

assessment and review of qualitative 

and quantitative contract evaluation 

objectives. 

The following categories will serve as 

the basis for the qualitative evaluation 

of the Technical Assistance Drivers as 

specified on Table 1 of section J–10 in 

the 10th Statement of Work: 

• Rapid Cycle Improvement in 

Quality Improvement Activities and 

Outputs. 

• Customer Focus and Value of the 

Quality Improvement Activities to 

Beneficiaries, Participants and CMS. 

• Ability To Prepare the Field To 

Sustain the Improvements. 

• Value Innovation. 

• Commitment to 

‘‘boundarilessness.’’ 

• Unconditional Teamwork. 

The quantitative evaluation of the 

QIOs will be based on the number of 

commitments secured, participants 


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Federal Register / Vol. 76, No. 149 / Wednesday, August 3, 2011 / Notices 46817 

engaged, and the results in achievement 

of the goals as specified on Tables 2 and 

3 in section J–10 of the 10th Statement 

of Work. 

The ‘‘Aims Tasks’’ the QIO will be 

evaluated on are as follows: 

C.6 Beneficiary and Family Centered 

Care: 

• Case Review; 

• Patient and Family Engagement 

Campaign. 

C.7 Improving Individual Patient 

Care: 

• Reduction of Healthcare Associated 

Infections (CLABSI, CAUTI, CDI, and 

SSI); 

• Reduction of Healthcare Acquired 

Conditions in Nursing Homes (Pressure 

Ulcers and the Use of Physical 

Restraints); 

• Reduction of Adverse Drug Events; 

• Hospital Inpatient and Outpatient 

Quality Reporting and Improvement. 

C.8 Integrating Care for Populations 

and Communities: 

• Reduction of Hospital Readmissions 

Through a Comprehensive Community 

Effort by Improving the Quality of Care 

for Medicare Beneficiaries Who 

Transition Among Care Settings. 

C.9 Improving Health for 

Populations and Communities: 

• Promotion of Immunizations, 

Colorectal, and Breast Cancer 

Screenings; 

• Cardiovascular Health Campaign; 

• Improving Participation in the 

Physician Quality Reporting System 

(PQRS); 

• Improving the Use of Electronic 

Health Records (EHRs) for Care 

Management; 

• Integrating Health Information 

Technology to Improve Care 

Coordination, Achieve Meaningful Use, 

and Achieve Prevention Goals. 

The ‘‘Driver Tasks’’ the QIO will be 

evaluated on are as follows: 

C.10.1 Supporting and Convening 

Learning and Action Networks. 

C.10.2 Technical Assistance; 

C.10.3 Care Reinvention Through 

Innovation Spread (CRISP) Model. 

If a QIO is not tasked to work on a 

specific area under an ‘‘Aim’’ and/or 

‘‘Driver,’’ the QIO will not be evaluated 

under that particular area. Any Special 

Innovation Project that the QIO may 

carry out will be evaluated separately 

and will not be considered in the overall 

evaluation criteria. 

In addition to the qualitative and 

quantitative evaluation in the 18th and 

27th months of the contract, we will 

conduct monitoring activities 

throughout the course of the contract 

and will act upon findings as necessary. 

The performance results of the 

evaluation at both time periods (that is, 

18 months and 27 months) will be used, 

in addition to ongoing monitoring 

activities, to determine the overall 

performance on the contract. 

18th Month Contract Evaluation 

The 18th month contract evaluation 

will determine if the QIO has met the 

performance evaluation criteria as 

specified in J–10 of this Statement of 

Work. The achievement within each of 

the ‘‘Aims’’ and ‘‘Drivers’’ will be 

evaluated on an individual basis for 

appropriate contract action. Though, in 

general, evaluation of each ‘‘Aim’’ and/ 

or ‘‘Driver’’ will relate only to that area, 

we reserve the right to take appropriate 

contract action in the event of failure in 

multiple ‘‘Aims’’ and/or ‘‘Drivers’’. 

18th Month Evaluation Criteria: 

• Pass: Criteria met for the ‘‘Aim’’ 

and/or ‘‘Driver’’ as specified in the 

evaluation section of the ‘‘Aim’’ and/or 

‘‘Driver.’’ 

• Fail: Criteria not met for the ‘‘Aim’’ 

and/or ‘‘Driver’’ as specified in the 

evaluation section of the ‘‘Aim’’ and/or 

‘‘Driver.’’ 

27th Month Contract Evaluation 

The 27th month contract evaluation 

will determine if the QIO has met the 

performance evaluation criteria as 

specified in each of the ‘‘Aims’’ and 

‘‘Drivers’’ areas of the 10th SOW. The 

achievement within the ‘‘Drivers’’ and 

‘‘Aims’’ will be evaluated on an 

individual basis for appropriate contract 

action. 

27th Month Evaluation Criteria: 

• Pass: Criteria met for the ‘‘Aim’’ 

and/or ‘‘Driver’’ as specified in the 

evaluation section of the ‘‘Aim’’ and/or 

‘‘Driver.’’ 

• Fail: Criteria not met for the ‘‘Aim’’ 

and/or ‘‘Driver’’ as specified in the 

evaluation section of the ‘‘Aim’’ and/or 

‘‘Driver.’’ 

Overall Contract Evaluation 

The results of the 18th and 27th 

month evaluation periods, in addition to 

ongoing monitoring activities, will be 

used to determine how the contractor 

performed on the overall contract. 

If we choose, we may notify the QIO 

of our intention not to renew the QIO 

contract and inform the QIO of their 

rights under the current statute. 

Any failure at the 18th or 27th month 

evaluation for any ‘‘Aim or Driver’’ may 

result in that QIO receiving an adverse 

past performance evaluation. Further, 

failure may impact on the QIO’s ability 

to continue similar work in or eligibility 

for award of the 11th SOW. 

The list of measures and performance 

criteria for each QIO will be recorded on 

the CMS Dashboard, which will be 

available on QIOnet (http:// 

qionet.sdps.org), the standard 

information system that supports the 

QIO Program. We will also post these 

measures on the publicly accessible 

CMS Web site (http://www.cms.gov). 

We will monitor the QIO’s 

performance on the ‘‘Aims’’ and 

‘‘Drivers’’ against established criteria on 

at least a quarterly basis, and may take 

appropriate contract action (for 

example, providing warning for the 

need for adjustment, instituting a formal 

correction plan, terminating an activity, 

or recommending early termination of a 

contract because of failure to meet 

contract timelines as specified in 

sections C.6 through C.10.). 

We reserve the right at any point, 

prior to the notification of our intention 

not to continue the option for an ‘‘Aim’’ 

and/or ‘‘Driver’’ and/or to renew the 

contract, to revise measures or adjust 

the expected minimum thresholds for 

satisfactory performance or remove 

criteria from an ‘‘Aim’’ and/or ‘‘Driver’’ 

evaluation protocol for any reason, 

including, but not limited to, data 

gathered based on experience with the 

amount of improvement achieved 

during the contract cycle or in pilot 

projects currently in progress, 

information gathered through evaluation 

of the QIO Program overall, or any 

unforeseen circumstances. Further, in 

accordance with standard contract 

procedures, we reserve the right at any 

time to discontinue an ‘‘Aim’’ and/or 

‘‘Driver’’ or any other part of this 

contract regardless of QIO performance 

on the ‘‘Aim’’ and/or ‘‘Driver’’. 

IV. Collection of Information 

Requirements 

This document does not impose 

information collection and 

recordkeeping requirements. 

Consequently, it need not be reviewed 

by the Office of Management and 

Budget under the authority of the 

Paperwork Reduction Act of 1995. 

V. Response to Comments 

Because of the large number of public 

comments we normally receive on 

Federal Register documents, we are not 

able to acknowledge or respond to them 

individually. We will consider all 

comments we receive by the date and 

time specified in the DATES section of 

this preamble, and, when we proceed 

with a subsequent document, we will 

respond to the comments in the 

preamble to that document. 

VI. Regulatory Impact Statement 

In accordance with the provisions of 

Executive Order 12866, this notice was 


srobinson on DSK4SPTVN1PROD with NOTICES
46818 Federal Register / Vol. 76, No. 149 / Wednesday, August 3, 2011 / Notices 

not reviewed by the Office of 

Management and Budget. 

(Catalog of Federal Domestic Assistance 

Program No. 93.773, Medicare—Hospital 

Insurance; and Program No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program) 

Dated: June 15, 2011. 

Donald M. Berwick, 

Administrator, Centers for Medicare & 

Medicaid Services. 

[FR Doc. 2011–19650 Filed 7–29–11; 4:15 pm] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0554] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Veterinary Feed 

Directive 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the Agency. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal Agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension of an existing collection of 

information, and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

reporting and recordkeeping 

requirements for distribution and use of 

Veterinary Feed Directive (VFD) drugs 

and animal feeds containing VFD drugs. 

DATES: Submit either electronic or 

written comments on the collection of 

information by October 3, 2011. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http:// 

www.regulations.gov. Submit written 

comments on the collection of 

information to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Juanmanuel Vilela, Office of 

Information Management, Food and 

Drug Administration, 1350 Piccard Dr., 

PI50–400B, Rockville, MD 20850, 301– 

796–7651, 

Juanmanuel.vilela@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Veterinary Feed Directive—21 CFR Part 

558 (OMB Control Number 0910– 

0363)—Extension 

With the passage of the Animal Drug 

Availability Act of 1996 (Pub. L. 104– 

250), the Congress enacted legislation 

establishing a new class of restricted 

feed use drugs, VFD drugs, which may 

be distributed without involving State 

pharmacy laws. Although controls on 

the distribution and use of VFD drugs 

are similar to those for prescription 

drugs regulated under section 503(f) of 

the Federal Food, Drug, and Cosmetic 

Act (21 U.S.C. 353(f)), the implementing 

VFD regulation (21 CFR 558.6) is 

tailored to the unique circumstances 

relating to the distribution of medicated 

feeds. The content of the VFD is spelled 

out in the regulation. All distributors of 

medicated feed containing VFD drugs 

must notify FDA of their intent to 

distribute, and records must be 

maintained of the distribution of all 

medicated feeds containing VFD drugs. 

The VFD regulation ensures the 

protection of public health while 

enabling animal producers to obtain and 

use needed drugs as efficiently and cost 

effectively as possible. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR section Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

558.6(a)(3) through (a)(5) .................................................... 15,000 25 375,000 .25 93,750 

558.6(d)(1)(i) through (d)(1)(iii) ............................................ 300 1 300 .25 75 

558.6(d)(1)(iv) ...................................................................... 20 1 20 .25 5 

558.6(d)(2) ........................................................................... 1,000 5 5,000 .25 1,250 

514.1(b)(9) ........................................................................... 1 1 1 3.00 3 

Total .............................................................................. ........................ ........................ ........................ ........................ 95,083 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 


srobinson on DSK4SPTVN1PROD with NOTICES