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 


daltland on DSKBBV9HB2PROD with NOTICES
Federal Register / Vol. 83, No. 140 / Friday, July 20, 2018 / Notices 34595 

require that State Refugee Resettlement 

and Wilson-Fish agencies, and local and 

Tribal governments complete Form 

ORR–6 in order to participate in the 

above-mentioned programs. 

Respondents: State governments, 

Replacement Designees, and Wilson/ 

Fish Alternative Projects. 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of 

responses 

per 

respondent 

Average 

burden hours 

per response 

Total burden 

hours 

ORR–6 Performance Report ........................................................................... 57 2 8 912 

Estimated Total Annual Burden 

Hours: 912. 

Copies of the proposed collection may 

be obtained by writing to the 

Administration for Children and 

Families, Office of Planning, Research 

and Evaluation, 330 C Street SW, 

Washington, DC 20201. Attention 

Reports Clearance Officer. All requests 

should be identified by the title of the 

information collection. Email address: 

infocollection@acf.hhs.gov. 

OMB Comment: OMB is required to 

make a decision concerning the 

collection of information between 30 

and 60 days after publication of this 

document in the Federal Register. 

Therefore, a comment is best assured of 

having its full effect if OMB receives it 

within 30 days of publication. Written 

comments and recommendations for the 

proposed information collection should 

be sent directly to the following: Office 

of Management and Budget, Paperwork 

Reduction Project, Email: OIRA_

SUBMISSION@OMB.EOP.GOV, Attn: 

Desk Officer for the Administration for 

Children and Families. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 2018–15537 Filed 7–19–18; 8:45 am] 

BILLING CODE 4184–45–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–D–0052] 

Documenting Electronic Data Files and 

Statistical Analysis Programs; Draft 

Guidance for Industry; Availability; 

Extension of Comment Period 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability; extension 

of comment period. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

extending the comment period for the 

notice of availability that published in 

the Federal Register on May 21, 2018. 

In that document, FDA requested 

comments on the draft revised guidance 

for industry (GFI) #197 entitled 

‘‘Documenting Electronic Data Files and 

Statistical Analysis Programs.’’ The 

Agency is taking this action in response 

to a request for an extension to allow 

interested persons additional time to 

submit comments. 

DATES: FDA is extending the comment 

period on the document published May 

21, 2018 (83 FR 23468). Submit either 

electronic or written comments on the 

draft revised guidance by October 18, 

2018, to ensure that the Agency 

considers your comment on this draft 

guidance before it begins work on the 

final version of the guidance. 

ADDRESSES: You may submit comments 

on any guidance at any time as follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2009–D–0052 for ‘‘Documenting 

Electronic Data Files and Statistical 

Analysis Programs.’’ Received 

comments will be placed in the docket 

and, except for those submitted as 

‘‘Confidential Submissions,’’ publicly 

viewable at https://www.regulations.gov 

or at the Dockets Management Staff 

between 9 a.m. and 4 p.m., Monday 

through Friday. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 


daltland on DSKBBV9HB2PROD with NOTICES