83 FR 34594 - Submission for OMB Review; Comment Request
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families Federal Register Volume 83, Issue 140 (July 20, 2018)
Administration for Children and Families
Federal Register Volume 83, Issue 140 (July 20, 2018)
| Page Range | 34594-34595 | |
| FR Document | 2018-15537 |
[Federal Register Volume 83, Number 140 (Friday, July 20, 2018)] [Notices] [Pages 34594-34595] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-15537] ----------------------------------------------------------------------- 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-by-State 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 [[Page 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 ---------------------------------------------------------------------------------------------------------------- Number of Average burden Instrument Number of responses per hours per Total burden respondents respondent response 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: [email protected]. 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: [email protected], 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
![34594 Federal Register / Vol. 83, No. 140 / Friday, July 20, 2018 / Notices
consumers who work to assist Medicare Plan for Adverse Drug Prevention medication safety and ADE prevention,
providers with quality improvement (2014). In addition to opioids, the the IEC developed an innovative
throughout the spectrum of care and to Action Plan focused on ADEs caused by approach, combining survey input with
review quality concerns for the other high-risk medication (HRM) modeling, to estimate the relative
protection of beneficiaries and the groups: Anticoagulants and diabetic importance of the QIN–QIO program.
Medicare Trust Fund. This program is a medications. Given the burden of ADEs The concept is supported at the highest
key component of the U.S. Department caused by these three classes of drugs, level of administration for Quality
of Health and Human Services’ (HHS) focusing prevention efforts in these Improvement at CMS and has been
National Quality Strategy and the CMS areas could have a significant impact on presented at national conferences and to
Quality Strategy. The work is aligned reducing harm and improving CMS/CCSQ leadership. The survey data
with the current HHS and CMS population health among Medicare is an essential component of this
administration priorities to empower beneficiaries. analytic method.
patients and doctors to make decisions The QIO program provides technical The information collected through the
about their health care; usher in a new assistance to reduce ADEs in survey will complement the existing
era of state flexibility and local beneficiaries resulting from data by helping identify factors
leadership; support innovative polypharmacy, specifically those who associated with ADE outcomes of
approaches to improve quality, use three or more medications including interest from existing data sets such as
accessibility, and affordability; and a prescription in a HRM) drug groups. Medicare claims. For example, claims
improve the CMS customer experience. In the 11th SOW, specific interventions data can provide information on
In the current SOW, 14 QIN–QIOs include training providers through whether the number of prescriptions for
coordinate the work in 53 U.S. states Learning Action Networks; developing opioids has decreased, but not what has
and territories. collaborations among local providers helped to facilitate the decrease. Form
CMS evaluates the quality and across care settings; providing materials Number: CMS–10675 (OMB control
effectiveness of the QIO program as and information resources; and helping number: 0938–NEW); Frequency:
authorized in Part B of Title XI of the providers collect data to monitor Annually; Affected Public: Private
Social Security Act. CMS created the prescribing practices. sector (Business or other for-profits);
Independent Evaluation Center (IEC) to To evaluate the effectiveness of this Number of Respondents: 1,200; Total
provide CMS and its stakeholders with program, we will use a mixed method Annual Responses: 1,200; Total Annual
an independent and objective program evaluation combining secondary data Hours: 300. (For policy questions
evaluation of the 11th SOW. analysis of Medicare claims with a regarding this collection contact Nancy
For the program to improve community provider survey. We plan to Sonnenfeld at 410–786–1294.)
medication safety and prevent adverse conduct an online survey of 1,200
drug events (ADEs), QIN–QIOs provide community-based pharmacists, Dated: July 16, 2018.
technical assistance to providers, physicians, and nursing home William N. Parham, III,
practitioners, organizations offering administrators or directors of nursing in Director, Paperwork Reduction Staff, Office
Medicare Advantage plans under nursing homes. These participants were of Strategic Operations and Regulatory
Medicare Part C, and prescription drug selected based on their role in Affairs.
sponsors offering drug plans under Part prescribing HRM and treating ADEs. [FR Doc. 2018–15466 Filed 7–19–18; 8:45 am]
D. ADEs are defined as ‘‘injury resulting The proposed survey assesses the BILLING CODE 4120–01–P
from medical intervention related to a extent to which the National Action
drug,’’ and cause the majority of Plan for Adverse Drug Prevention
preventable deaths in hospitals. ADEs strategies have been used, the level of DEPARTMENT OF HEALTH AND
escalate healthcare costs and utilization, engagement with the QIO, and other HUMAN SERVICES
increasing admission and readmission influences that can help explain
rates, emergency department (ED) visits, progress towards the goals of the QIN– Administration for Children and
and physician visits. ADEs are QIO SOW. The questions used for these Families
particularly problematic for older adults constructs related to program and non-
Submission for OMB Review;
who have multiple chronic conditions program influences have been adopted
Comment Request
and interact with many care settings. from previously used and/or validated
Opioid misuse and overdose is a instruments, including the IEC Nursing Title: ORR–6, ORR Requirements for
significant cause of ADEs and was Home Survey that was approved under Refugee Cash Assistance; and Refugee
declared a public health emergency by OMB control number 0938–1330. Medical Assistance (45 CFR part 400).
the White House in 2017. In 2016, over The survey will also provide OMB No.: 0970–0036.
14 million Medicare Part D beneficiaries estimates of the attribution of the QIN– Description: As required by section
received opioid prescriptions, and many QIO program for improving ADE 412(e) of the Immigration and
of these beneficiaries received extreme prevention, and reported impact of the Nationality Act, the Administration for
amounts of the drugs. The Medicare QIN–QIO program from the perspective Children and Families (ACF), Office of
population has one of the highest and of healthcare providers. The perceived Refugee Resettlement (ORR), is
fastest-growing rates of diagnosed influence on quality improvement requesting the information from Form
opioid use disorder. efforts will be quantified and, along ORR–6 to determine the effectiveness of
As part of the HHS Opioid Initiative with econometric modeling methods, the State cash and medical assistance,
launched in March 2015, CMS will be used to assess program and social services programs. State-by-
daltland on DSKBBV9HB2PROD with NOTICES
developed a multipronged approach to attribution. Estimating attribution is a State Refugee Cash Assistance (RCA)
combat misuse and promote programs contract requirement for the IEC and and Refugee Medical Assistance (RMA)
that support treatment and recovery helps provide evidence of impact of the utilization rates derived from Form
support services for clinicians, QIN–QIO program. Since current ORR–6 are calculated for use in
beneficiaries, and families. CMS also analytical methods do not adequately formulating program initiatives,
worked with HHS and other health address the overlap of quality priorities, standards, budget requests,
agencies to develop a National Action improvement initiatives targeting and assistance policies. ORR regulations
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![Federal Register / Vol. 83, No. 140 / Friday, July 20, 2018 / Notices 34595
require that State Refugee Resettlement ORR–6 in order to participate in the Respondents: State governments,
and Wilson-Fish agencies, and local and above-mentioned programs. Replacement Designees, and Wilson/
Tribal governments complete Form Fish Alternative Projects.
ANNUAL BURDEN ESTIMATES
Number of Average
Number of responses Total burden
Instrument burden hours
respondents per hours
per response
respondent
ORR–6 Performance Report ........................................................................... 57 2 8 912
Estimated Total Annual Burden In that document, FDA requested Written/Paper Submissions
Hours: 912. comments on the draft revised guidance Submit written/paper submissions as
Copies of the proposed collection may for industry (GFI) #197 entitled follows:
be obtained by writing to the ‘‘Documenting Electronic Data Files and • Mail/Hand delivery/Courier (for
Administration for Children and Statistical Analysis Programs.’’ The written/paper submissions): Dockets
Families, Office of Planning, Research Agency is taking this action in response Management Staff (HFA–305), Food and
and Evaluation, 330 C Street SW, to a request for an extension to allow Drug Administration, 5630 Fishers
Washington, DC 20201. Attention interested persons additional time to Lane, Rm. 1061, Rockville, MD 20852.
Reports Clearance Officer. All requests submit comments. • For written/paper comments
should be identified by the title of the submitted to the Dockets Management
information collection. Email address: DATES: FDA is extending the comment Staff, FDA will post your comment, as
infocollection@acf.hhs.gov. period on the document published May well as any attachments, except for
OMB Comment: OMB is required to 21, 2018 (83 FR 23468). Submit either information submitted, marked and
make a decision concerning the electronic or written comments on the identified, as confidential, if submitted
collection of information between 30 draft revised guidance by October 18, as detailed in ‘‘Instructions.’’
and 60 days after publication of this 2018, to ensure that the Agency Instructions: All submissions received
document in the Federal Register. considers your comment on this draft must include the Docket No. FDA–
Therefore, a comment is best assured of guidance before it begins work on the 2009–D–0052 for ‘‘Documenting
having its full effect if OMB receives it final version of the guidance. Electronic Data Files and Statistical
within 30 days of publication. Written Analysis Programs.’’ Received
comments and recommendations for the ADDRESSES: You may submit comments
on any guidance at any time as follows: comments will be placed in the docket
proposed information collection should and, except for those submitted as
be sent directly to the following: Office Electronic Submissions ‘‘Confidential Submissions,’’ publicly
of Management and Budget, Paperwork viewable at https://www.regulations.gov
Reduction Project, Email: OIRA_ Submit electronic comments in the or at the Dockets Management Staff
SUBMISSION@OMB.EOP.GOV, Attn: following way: between 9 a.m. and 4 p.m., Monday
Desk Officer for the Administration for • Federal eRulemaking Portal: through Friday.
Children and Families. https://www.regulations.gov. Follow the • Confidential Submissions—To
Robert Sargis, instructions for submitting comments. submit a comment with confidential
Comments submitted electronically, information that you do not wish to be
Reports Clearance Officer.
including attachments, to https:// made publicly available, submit your
[FR Doc. 2018–15537 Filed 7–19–18; 8:45 am]
www.regulations.gov will be posted to comments only as a written/paper
BILLING CODE 4184–45–P
the docket unchanged. Because your submission. You should submit two
comment will be made public, you are copies total. One copy will include the
solely responsible for ensuring that your information you claim to be confidential
DEPARTMENT OF HEALTH AND
comment does not include any with a heading or cover note that states
HUMAN SERVICES
confidential information that you or a ‘‘THIS DOCUMENT CONTAINS
Food and Drug Administration third party may not wish to be posted, CONFIDENTIAL INFORMATION.’’ The
such as medical information, your or Agency will review this copy, including
[Docket No. FDA–2009–D–0052] the claimed confidential information, in
anyone else’s Social Security number, or
confidential business information, such its consideration of comments. The
Documenting Electronic Data Files and
second copy, which will have the
Statistical Analysis Programs; Draft as a manufacturing process. Please note
claimed confidential information
Guidance for Industry; Availability; that if you include your name, contact
redacted/blacked out, will be available
Extension of Comment Period information, or other information that
for public viewing and posted on
identifies you in the body of your
AGENCY: Food and Drug Administration, https://www.regulations.gov. Submit
comments, that information will be
HHS. both copies to the Dockets Management
posted on https://www.regulations.gov. Staff. If you do not wish your name and
ACTION:Notice of availability; extension
daltland on DSKBBV9HB2PROD with NOTICES
of comment period. • If you want to submit a comment contact information to be made publicly
with confidential information that you available, you can provide this
SUMMARY: The Food and Drug do not wish to be made available to the information on the cover sheet and not
Administration (FDA or Agency) is public, submit the comment as a in the body of your comments and you
extending the comment period for the written/paper submission and in the must identify this information as
notice of availability that published in manner detailed (see ‘‘Written/Paper ‘‘confidential.’’ Any information marked
the Federal Register on May 21, 2018. Submissions’’ and ‘‘Instructions’’). as ‘‘confidential’’ will not be disclosed
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Document Created: 2018-07-20 01:18:28
Document Modified: 2018-07-20 01:18:28
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| FR Citation | 83 FR 34594 |
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