Federal Register / Vol. 83, No. 140 / Friday, July 20, 2018 / Notices 34593 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondents Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total burden 

(in hours) 

Veterinarian ....................................... ........................................................... 500 1 15/60 125 

Total ........................................... ........................................................... ........................ ........................ ........................ 125 

Jeffrey M. Zirger, 

Acting Chief, Information Collection Review 

Office, Office of Scientific Integrity, Office 

of the Associate Director for Science, Office 

of the Director, Centers for Disease Control 

and Prevention. 

[FR Doc. 2018–15528 Filed 7–19–18; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier CMS–10675] 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

AGENCY: Centers for Medicare & 

Medicaid Services, HHS. 

ACTION: Notice. 

SUMMARY: The Centers for Medicare & 

Medicaid Services (CMS) is announcing 

an opportunity for the public to 

comment on CMS’ intention to collect 

information from the public. 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 or reinstatement of an existing 

collection of information) and to allow 

60 days for public comment on the 

proposed action. Interested persons are 

invited to send comments regarding our 

burden estimates or any other aspect of 

this collection of information, including 

the necessity and utility of the proposed 

information collection for the proper 

performance of the agency’s functions, 

the accuracy of the estimated burden, 

ways to enhance the quality, utility, and 

clarity of the information to be 

collected, and the use of automated 

collection techniques or other forms of 

information technology to minimize the 

information collection burden. 

DATES: Comments must be received by 

September 18, 2018. 

ADDRESSES: When commenting, please 

reference the document identifier or 

OMB control number. To be assured 

consideration, comments and 

recommendations must be submitted in 

any one of the following ways: 

1. Electronically. You may send your 

comments electronically to http://

www.regulations.gov. Follow the 

instructions for ‘‘Comment or 

Submission’’ or ‘‘More Search Options’’ 

to find the information collection 

document(s) that are accepting 

comments. 

2. By regular mail. You may mail 

written comments to the following 

address: CMS, Office of Strategic 

Operations and Regulatory Affairs, 

Division of Regulations Development, 

Attention: Document Identifier/OMB 

Control Number ll, Room C4–26–05, 

7500 Security Boulevard, Baltimore, 

Maryland 21244–1850. 

To obtain copies of a supporting 

statement and any related forms for the 

proposed collection(s) summarized in 

this notice, you may make your request 

using one of following: 

1. Access CMS’ website address at 

https://www.cms.gov/Regulations-andGuidance/Legislation/Paperwork

ReductionActof1995/PRA-Listing.html. 

2. Email your request, including your 

address, phone number, OMB number, 

and CMS document identifier, to 

Paperwork@cms.hhs.gov. 

3. Call the Reports Clearance Office at 

(410) 786–1326. 

FOR FURTHER INFORMATION CONTACT: 

William Parham at (410) 786–4669. 

SUPPLEMENTARY INFORMATION: 

Contents 

This notice sets out a summary of the 

use and burden associated with the 

following information collections. More 

detailed information can be found in 

each collection’s supporting statement 

and associated materials (see 

ADDRESSES). 

CMS–10675 Evaluation of the CMS 

Quality Improvement Organizations: 

Medication Safety and Adverse Drug 

Event Prevention 

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. 

The term ‘‘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 

requires federal agencies to publish a 

60-day notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension or reinstatement of an existing 

collection of information, before 

submitting the collection to OMB for 

approval. To comply with this 

requirement, CMS is publishing this 

notice. 

Information Collection 

1. Type of Information Collection 

Request: New Collection of Information 

Request; Title of Information Collection: 

Evaluation of the CMS Quality 

Improvement Organizations: Medication 

Safety and Adverse Drug Event 

Prevention; Use: The purpose of this 

Information Collection Request (ICR) is 

to collect data to inform the program 

evaluation of the Centers for Medicare & 

Medicaid Services (CMS) Quality 

Improvement Organizations (QIO) 

current contract known as the 11th 

Scope of Work (SOW). The current ICR 

focuses on evaluating one component of 

the quality improvement activities of 

the Quality Innovation Network Quality 

Improvement Organizations (QIN–QIOs) 

and is part of a larger evaluation of the 

overall impact of the QIO program. This 

ICR aims to assess the QIN–QIO Task 

which focuses on Medication Safety and 

Adverse Drug Event Prevention. For this 

evaluation, we are using a mixedmethods design to compare quality 

improvement activities of pharmacists, 

physicians, and nursing home 

administrators or directors of nursing at 

nursing homes participating in the QIN– 

QIO program (participating) with those 

not participating in the QIN–QIO 

program (non-participating). 

As mandated by Sections 1152–1154 

of the Social Security Act, CMS directs 

the QIO program, which is one of the 

largest federal programs dedicated to 

improving health quality for Medicare 

beneficiaries. QIOs are groups of health 

quality experts, clinicians, and 


daltland on DSKBBV9HB2PROD with NOTICES
34594 Federal Register / Vol. 83, No. 140 / Friday, July 20, 2018 / Notices 

consumers who work to assist Medicare 

providers with quality improvement 

throughout the spectrum of care and to 

review quality concerns for the 

protection of beneficiaries and the 

Medicare Trust Fund. This program is a 

key component of the U.S. Department 

of Health and Human Services’ (HHS) 

National Quality Strategy and the CMS 

Quality Strategy. The work is aligned 

with the current HHS and CMS 

administration priorities to empower 

patients and doctors to make decisions 

about their health care; usher in a new 

era of state flexibility and local 

leadership; support innovative 

approaches to improve quality, 

accessibility, and affordability; and 

improve the CMS customer experience. 

In the current SOW, 14 QIN–QIOs 

coordinate the work in 53 U.S. states 

and territories. 

CMS evaluates the quality and 

effectiveness of the QIO program as 

authorized in Part B of Title XI of the 

Social Security Act. CMS created the 

Independent Evaluation Center (IEC) to 

provide CMS and its stakeholders with 

an independent and objective program 

evaluation of the 11th SOW. 

For the program to improve 

medication safety and prevent adverse 

drug events (ADEs), QIN–QIOs provide 

technical assistance to providers, 

practitioners, organizations offering 

Medicare Advantage plans under 

Medicare Part C, and prescription drug 

sponsors offering drug plans under Part 

D. ADEs are defined as ‘‘injury resulting 

from medical intervention related to a 

drug,’’ and cause the majority of 

preventable deaths in hospitals. ADEs 

escalate healthcare costs and utilization, 

increasing admission and readmission 

rates, emergency department (ED) visits, 

and physician visits. ADEs are 

particularly problematic for older adults 

who have multiple chronic conditions 

and interact with many care settings. 

Opioid misuse and overdose is a 

significant cause of ADEs and was 

declared a public health emergency by 

the White House in 2017. In 2016, over 

14 million Medicare Part D beneficiaries 

received opioid prescriptions, and many 

of these beneficiaries received extreme 

amounts of the drugs. The Medicare 

population has one of the highest and 

fastest-growing rates of diagnosed 

opioid use disorder. 

As part of the HHS Opioid Initiative 

launched in March 2015, CMS 

developed a multipronged approach to 

combat misuse and promote programs 

that support treatment and recovery 

support services for clinicians, 

beneficiaries, and families. CMS also 

worked with HHS and other health 

agencies to develop a National Action 

Plan for Adverse Drug Prevention 

(2014). In addition to opioids, the 

Action Plan focused on ADEs caused by 

other high-risk medication (HRM) 

groups: Anticoagulants and diabetic 

medications. Given the burden of ADEs 

caused by these three classes of drugs, 

focusing prevention efforts in these 

areas could have a significant impact on 

reducing harm and improving 

population health among Medicare 

beneficiaries. 

The QIO program provides technical 

assistance to reduce ADEs in 

beneficiaries resulting from 

polypharmacy, specifically those who 

use three or more medications including 

a prescription in a HRM) drug groups. 

In the 11th SOW, specific interventions 

include training providers through 

Learning Action Networks; developing 

collaborations among local providers 

across care settings; providing materials 

and information resources; and helping 

providers collect data to monitor 

prescribing practices. 

To evaluate the effectiveness of this 

program, we will use a mixed method 

evaluation combining secondary data 

analysis of Medicare claims with a 

community provider survey. We plan to 

conduct an online survey of 1,200 

community-based pharmacists, 

physicians, and nursing home 

administrators or directors of nursing in 

nursing homes. These participants were 

selected based on their role in 

prescribing HRM and treating ADEs. 

The proposed survey assesses the 

extent to which the National Action 

Plan for Adverse Drug Prevention 

strategies have been used, the level of 

engagement with the QIO, and other 

influences that can help explain 

progress towards the goals of the QIN– 

QIO SOW. The questions used for these 

constructs related to program and nonprogram influences have been adopted 

from previously used and/or validated 

instruments, including the IEC Nursing 

Home Survey that was approved under 

OMB control number 0938–1330. 

The survey will also provide 

estimates of the attribution of the QIN– 

QIO program for improving ADE 

prevention, and reported impact of the 

QIN–QIO program from the perspective 

of healthcare providers. The perceived 

influence on quality improvement 

efforts will be quantified and, along 

with econometric modeling methods, 

will be used to assess program 

attribution. Estimating attribution is a 

contract requirement for the IEC and 

helps provide evidence of impact of the 

QIN–QIO program. Since current 

analytical methods do not adequately 

address the overlap of quality 

improvement initiatives targeting 

medication safety and ADE prevention, 

the IEC developed an innovative 

approach, combining survey input with 

modeling, to estimate the relative 

importance of the QIN–QIO program. 

The concept is supported at the highest 

level of administration for Quality 

Improvement at CMS and has been 

presented at national conferences and to 

CMS/CCSQ leadership. The survey data 

is an essential component of this 

analytic method. 

The information collected through the 

survey will complement the existing 

data by helping identify factors 

associated with ADE outcomes of 

interest from existing data sets such as 

Medicare claims. For example, claims 

data can provide information on 

whether the number of prescriptions for 

opioids has decreased, but not what has 

helped to facilitate the decrease. Form 

Number: CMS–10675 (OMB control 

number: 0938–NEW); Frequency: 

Annually; Affected Public: Private 

sector (Business or other for-profits); 

Number of Respondents: 1,200; Total 

Annual Responses: 1,200; Total Annual 

Hours: 300. (For policy questions 

regarding this collection contact Nancy 

Sonnenfeld at 410–786–1294.) 

Dated: July 16, 2018. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2018–15466 Filed 7–19–18; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Submission for OMB Review; 

Comment Request 

Title: ORR–6, ORR Requirements for 

Refugee Cash Assistance; and Refugee 

Medical Assistance (45 CFR part 400). 

OMB No.: 0970–0036. 

Description: As required by section 

412(e) of the Immigration and 

Nationality Act, the Administration for 

Children and Families (ACF), Office of 

Refugee Resettlement (ORR), is 

requesting the information from Form 

ORR–6 to determine the effectiveness of 

the State cash and medical assistance, 

and social services programs. State-byState Refugee Cash Assistance (RCA) 

and Refugee Medical Assistance (RMA) 

utilization rates derived from Form 

ORR–6 are calculated for use in 

formulating program initiatives, 

priorities, standards, budget requests, 

and assistance policies. ORR regulations 


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