Federal Register / Vol. 85, No. 239 / Friday, December 11, 2020 / Notices 80113 

grant or deny a hospital’s request for an 

exception to the prohibition on 

expansion of facility capacity must be 

published in the Federal Register in 

accordance with our regulations at 

§ 411.362(c)(7). 

IV. Hospital Exception Request 

As permitted by section 1877(i)(3) of 

the Act and our regulations at 

§ 411.362(c), the following physicianowned hospital has requested an 

exception to the prohibition on 

expansion of facility capacity: 

Name of Facility: Solutions Medical 

Consulting, LLC d/b/a Serenity 

Springs Hospital 

Location: 1495 Frazier Road, Ruston, 

Louisiana 71270–1632 

Basis for Exception Request: High 

Medicaid Facility 

We seek comments on this request 

from individuals and entities in the 

community in which the hospital is 

located. We encourage interested parties 

to review the hospital’s request, which 

is posted on the CMS website at: http:// 

www.cms.gov/Medicare/Fraud-andAbuse/PhysicianSelfReferral/Physician_

Owned_Hospitals.html. We solicit 

public comments regarding whether the 

hospital qualifies as a high Medicaid 

facility. Under § 411.362(c)(3), a high 

Medicaid facility is a hospital that 

satisfies all of the following criteria: 

• Is not the sole hospital in the 

county in which the hospital is located. 

• With respect to each of the 3 most 

recent 12-month periods for which data 

are available as of the date the hospital 

submits its request, has an annual 

percent of total inpatient admissions 

under Medicaid that is estimated to be 

greater than such percent with respect 

to such admissions for any other 

hospital located in the county in which 

the hospital is located. 

• Does not discriminate against 

beneficiaries of Federal health care 

programs and does not permit 

physicians practicing at the hospital to 

discriminate against such beneficiaries. 

Individuals and entities wishing to 

submit comments on the hospital’s 

request should review the ‘‘DATES’’ and 

‘‘ADDRESSES’’ sections above and state 

whether or not they are in the 

community in which the hospital is 

located. 

V. Collection of Information 

Requirements 

This document does not impose 

information collection requirements, 

that is, reporting, recordkeeping or 

third-party disclosure requirements. 

Consequently, there is no need for 

review by the Office of Management and 

Budget under the authority of the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 3501 et seq.). 

VI. 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. 

The Administrator of the Centers for 

Medicare & Medicaid Services (CMS), 

Seema Verma, having reviewed and 

approved this document, authorizes 

Lynette Wilson, who is the Federal 

Register Liaison, to electronically sign 

this document for purposes of 

publication in the Federal Register. 

Dated: December 8, 2020. 

Lynette Wilson, 

Federal Register Liaison, Centers for Medicare 

& Medicaid Services. 

[FR Doc. 2020–27354 Filed 12–10–20; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Submission for OMB Review; ORR–3 

and ORR–4 Report Forms for the 

Unaccompanied Refugee Minors 

Program (OMB #0970–0034) 

AGENCY: Office of Refugee Resettlement, 

Administration for Children and 

Families, HHS. 

ACTION: Request for Public Comment. 

SUMMARY: The Office of Refugee 

Resettlement (ORR) is requesting a 3- 

year extension of the ORR–3 and ORR– 

4 Report Forms (OMB #0970–0034, 

expiration 01/31/2021). ORR proposes 

revisions to improve clarity, secure 

outcome-based data, increase 

compliance with reporting 

requirements, and reduce burden. 

DATES: Comments due within 30 days of 

publication. OMB must make a decision 

about 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. 

ADDRESSES: Written comments and 

recommendations for the proposed 

information collection should be sent 

within 30 days of publication of this 

notice to www.reginfo.gov/public/do/ 

PRAMain. Find this particular 

information collection by selecting 

‘‘Currently under 30-day Review—Open 

for Public Comments’’ or by using the 

search function. 

SUPPLEMENTARY INFORMATION: 

Description: The ORR–3 Report is 

submitted within 30 days of the minor’s 

initial placement in the state, within 60 

days of a change in the minor’s status 

(e.g., change in legal responsibility, 

change in foster home placement, 

change in immigration data), and within 

60 days of termination from the 

program. The ORR–4 Report is 

submitted every 12 months beginning 

on the first anniversary of the initial 

placement date, to record outcomes of 

the minor’s progress. 

Respondents: Unaccompanied 

Refugee Minors (URM) State Agencies, 

URM Provider Agencies, and Youth 

Participants. 

Annual Burden Estimates: URM State 

Agencies. 

Instrument 

Total 

number of 

respondents 

Total 

number of 

responses per 

respondent 

Average 

burden 

hours per 

response 

Total 

burden 

hours 

Annual 

burden 

hours 

ORR–3 Unaccompanied Refugee Minors Placement Report ................................................................................... 15 432 0.25 1,620 540 

ORR–4 Unaccompanied Refugee Minors Outcomes Report ................................................................................... 15 282 0.50 2,115 705 


jbell on DSKJLSW7X2PROD with NOTICES
80114 Federal Register / Vol. 85, No. 239 / Friday, December 11, 2020 / Notices 

Estimated Total Annual Burden 

Hours (State Agencies): 1,245. 

Annual Burden Estimates: URM 

Provider Agencies. 

Instrument 

Total 

number of 

respondents 

Total 

number of 

responses per 

respondent 

Average 

burden 

hours per 

response 

Total 

burden 

hours 

Annual 

burden 

hours 

ORR–3 Unaccompanied Refugee Minors Placement Report ................................................................................... 24 270 0.50 3,240 1,080 

ORR–4 Unaccompanied Refugee Minors Outcomes Report ................................................................................... 24 162 1.0 3,888 1,296 

Estimated Total Annual Burden 

Hours (Provider Agencies): 2,376. 

Annual Burden Estimates: Youth 

Participants. 

Instrument 

Total 

number of 

respondents 

Total 

number of 

responses per 

respondent 

Average burden 

hours per 

response 

Total 

burden 

hours 

Annual 

burden 

hours 

ORR–4 Unaccompanied Refugee Minors Outcomes Report ................................................................................... 1032 3 0.50 1,548 516 

Estimated Total Annual Burden 

Hours (Youth Participants): 516. 

Total Estimated Annual Burden 

Hours: 4,137. 

Authority: 8 U.S.C. 1522(d). 

Mary B. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2020–27194 Filed 12–10–20; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2019–D–1647, FDA– 

2019–D–1652, and FDA–2019–D–1650] 

Performance Criteria for Safety and 

Performance Based Pathway; 

Guidances for Industry and Food and 

Drug Administration Staff; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of three 

device-specific final guidance 

documents for the Safety and 

Performance Based Pathway— 

specifically, ‘‘Spinal Plating Systems— 

Performance Criteria for Safety and 

Performance Based Pathway; Guidance 

for Industry and Food and Drug 

Administration Staff,’’ ‘‘Orthopedic 

Non-Spinal Metallic Bone Screws and 

Washers—Performance Criteria for 

Safety and Performance Based Pathway; 

Guidance for Industry and Food and 

Drug Administration Staff,’’ and 

‘‘Magnetic Resonance (MR) Receiveonly Coil—Performance Criteria for 

Safety and Performance Based Pathway; 

Guidance for Industry and Food and 

Drug Administration Staff.’’ The devicespecific guidances identified in this 

notice were developed in accordance 

with the final guidance entitled ‘‘Safety 

and Performance Based Pathway.’’ 

DATES: The announcement of the 

guidances is published in the Federal 

Register on December 11, 2020. 

ADDRESSES: You may submit either 

electronic or written comments on 

Agency guidances 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– 

2019–D–1647 for ‘‘Spinal Plating 

Systems—Performance Criteria for 

Safety and Performance Based Pathway; 

Guidance for Industry and Food and 

Drug Administration Staff,’’ Docket No. 

FDA–2019–D–1652 for ‘‘Orthopedic 

Non-Spinal Metallic Bone Screws and 

Washers—Performance Criteria for 

Safety and Performance Based Pathway; 

Guidance for Industry and Food and 

Drug Administration Staff,’’ and Docket 

No. FDA–2019–D–1650 for ‘‘Magnetic 

Resonance (MR) Receive-only Coil— 

Performance Criteria for Safety and 

Performance Based Pathway; Guidance 

for Industry and Food and Drug 

Administration Staff.’’ 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 


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