29118 Federal Register / Vol. 83, No. 121 / Friday, June 22, 2018 / Notices 

via the Federal eRulemaking portal by 

searching for the OMB Control number 

9000–0198. Select the link ‘‘Comment 

Now’’ that corresponds with 

‘‘Information Collection 9000–0198; 

Violations of Arms Control Treaties or 

Agreements with the United States.’’ 

Follow the instructions on the screen. 

Please include your name, company 

name (if any), and ‘‘Information 

Collection 9000–0198; Violations of 

Arms Control Treaties or Agreements 

with the United States.’’ 

• Mail: General Services 

Administration, Regulatory Secretariat 

Division (MVCB), 1800 F Street NW, 

Washington, DC 20405–0001. ATTN: 

Ms. Mandell/IC 9000–0198; Violations 

of Arms Control Treaties or Agreements 

with the United States. 

Instructions: Please submit comments 

only and cite Information Collection 

9000–0198; Violations of Arms Control 

Treaties or Agreements with the United 

States, in all correspondence related to 

this collection. Comments received 

generally will be posted without change 

to http://www.regulations.gov, including 

any personal and/or business 

confidential information provided. To 

confirm receipt of your comment(s), 

please check www.regulations.gov, 

approximately two-to-three days after 

submission to verify posting (except 

allow 30 days for posting of comments 

submitted by mail). 

SUPPLEMENTARY INFORMATION: 

A. Purpose 

The Paperwork Reduction Act of 1995 

(44 U.S.C. 3501 et seq.) (PRA) provides 

that an agency generally cannot conduct 

or sponsor a collection of information, 

and no person is required to respond to 

nor be subject to a penalty for failure to 

comply with a collection of information, 

unless that collection has obtained 

Office of Management and Budget 

(OMB) approval and displays a 

currently valid OMB Control Number. 

DoD, GSA, and NASA requested and 

OMB authorized emergency processing 

of an information collection involved in 

this rule, as OMB Control Number 

9000–0198 (FAR case 2017–018, 

52.209–13, Violation of Arms Control 

Treaties or Agreements—Certifications) 

consistent with 5 CFR 1320.13. DoD, 

GSA, and NASA have determined the 

following conditions have been met: 

a. The collection of information is 

needed prior to the expiration of time 

periods normally associated with a 

routine submission for review under the 

provisions of the Paperwork Reduction 

Act. 

b. The collection of information is 

essential to the mission of the agencies 

to ensure the Federal Government does 

not award contracts to offerors, and any 

entity owned or controlled by the 

offeror that has engaged in any activity 

that violates arms control treaties or 

agreements with the United States. 

c. The use of normal clearance 

procedures would prevent the collection 

of information from contractors, for 

national security purposes. 

Section 1290 of Public Law 114–328 

(codified at 22 U.S.C. 2593e) went into 

effect on December 23, 2016. The 

implementation of this FAR case will 

protect against doing business with 

entities that engage in any activity that 

contributed to or is a significant factor 

in a country’s failure to comply with 

arms control treaties or agreements with 

the United States. This action is 

necessary because of statutory 

requirements relating to a national 

security function of the United States. 

A notice was published in the Federal 

Register at 83 FR 28145, on June 15, 

2018, as a part of a interim rule under 

FAR Case 2017–018, Violations of Arms 

Control Treaties or Agreements with the 

United States. 

B. Annual Reporting Burden 

Number of Respondents: 11,634. 

Responses per Respondent: 8.6. 

Total Responses: 99,796. 

Average Burden Hours per Response: 

.4 hours. 

Total Burden Hours: 40,478. 

C. Public Comments 

Public comments are particularly 

invited on: Whether this collection of 

information is necessary for the proper 

performance of functions of the FAR, 

and will have practical utility; whether 

the estimate of the public burden of this 

collection of information is accurate, 

and based on valid assumptions and 

methodology; ways to enhance the 

quality, utility, and clarity of the 

information to be collected; and ways to 

minimize the burden of the collection of 

information on those entities who will 

respond, through the use of appropriate 

technological collection techniques or 

other forms of information technology. 

Obtaining Copies of Proposals: 

Requesters may obtain a copy of the 

information collection documents from 

the General Services Administration, 

Regulatory Secretariat Division (MVCB), 

1800 F Street NW, Washington, DC 

20405, telephone 202–501–4755. Please 

cite OMB Control No. 9000–0198, 

Violations of Arms Control Treaties or 

Agreements with the United States. 

Dated: June 18, 2018. 

William F. Clark, 

Director, Office of Governmentwide 

Acquisition Policy, Office of Acquisition 

Policy, Office of Governmentwide Policy. 

[FR Doc. 2018–13403 Filed 6–21–18; 8:45 am] 

BILLING CODE 6820–EP–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–3351–FN] 

Medicare and Medicaid Programs; 

Application by The Compliance Team 

for Continued CMS Approval of Its 

Rural Health Clinic Accreditation 

Program 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Final notice. 

SUMMARY: This final notice announces 

our decision to approve The 

Compliance Team (TCT) for continued 

recognition as a national accrediting 

organization for Rural Health Clinics 

(RHCs) that wish to participate in the 

Medicare or Medicaid programs. 

DATES: Applicable Date: This notice is 

effective July 18, 2018 through July 18, 

2024. 

FOR FURTHER INFORMATION CONTACT: 

Christina Mister-Ward, (410) 786– 

2441. 

Monda Shaver, (410) 786–3410. 

Marie Vasbinder, 410–786–8665. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Under the Medicare program, eligible 

beneficiaries may receive covered 

services in a rural health clinic (RHC) 

provided certain requirements are met 

by the RHC. Section 1861(aa) and 

1905(l)(1) of the Social Security Act (the 

Act), establish distinct criteria for 

facilities seeking designation as a RHC. 

Regulations concerning provider 

agreements are at 42 CFR part 489 and 

those pertaining to activities relating to 

the survey and certification of facilities 

are at 42 CFR part 488, subpart A. The 

regulations at 42 CFR part 491, subpart 

A specify the conditions that a RHC 

must meet to participate in the Medicare 

program. The scope of covered services 

and the conditions for Medicare 

payment for RHCs are set forth at 42 

CFR part 405, subpart X. 

Generally, to enter into a provider 

agreement with the Medicare program, a 

RHC must first be certified by a state 

survey agency as complying with the 


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Federal Register / Vol. 83, No. 121 / Friday, June 22, 2018 / Notices 29119 

conditions or requirements set forth in 

42 CFR part 491. Thereafter, the RHC is 

subject to regular surveys by a state 

survey agency to determine whether it 

continues to meet these requirements. 

There is an alternative, however, to 

surveys by state agencies. Section 

1865(a)(1) of the Act provides that, if a 

provider entity demonstrates through 

accreditation by an approved national 

accrediting organization that all 

applicable Medicare conditions are met 

or exceeded, we will deem those 

provider entities as having met the 

requirements. Accreditation by an 

accrediting organization is voluntary 

and is not required for Medicare 

participation. 

If an accrediting organization is 

recognized by the Secretary as having 

standards for accreditation that meet or 

exceed Medicare requirements, any 

provider entity accredited by the 

national accrediting body’s approved 

program would be deemed to meet the 

Medicare conditions. A national 

accrediting organization applying for 

CMS approval of its accreditation 

program under 42 CFR part 488, subpart 

A, must provide us with reasonable 

assurance that the accrediting 

organization requires the accredited 

provider entities to meet requirements 

that are at least as stringent as the 

Medicare conditions. Our regulations 

concerning the approval of accrediting 

organizations are set forth at § 488.5. 

Section 488.5(e)(2)(i) requires an 

accrediting organization to reapply for 

continued approval of its accreditation 

program every 6 years or as determined 

by CMS. The Compliance Team’s 

(TCT’s) current term of approval for its 

RHC accreditation program expires July 

18, 2018. 

II. Application Approval Process 

Section 1865(a)(3)(A) of the Act 

provides a statutory timetable to ensure 

that our review of applications for CMSapproval of an accreditation program is 

conducted in a timely manner. The Act 

provides us 210 days after the date of 

receipt of a complete application, with 

any documentation necessary to make 

the determination, to complete our 

survey activities and application 

process. Within 60 days after receiving 

a complete application, we must 

publish a notice in the Federal Register 

that identifies the national accrediting 

body making the request, describes the 

request, and provides no less than a 30- 

day public comment period. At the end 

of the 210-day period, we must publish 

a notice in the Federal Register 

approving or denying the application. 

III. Provisions of the Proposed Notice 

In the January 23, 2018 Federal 

Register (83 FR 3152), we published a 

notice announcing TCT’s request for 

continued approval of its RHC 

accreditation program. In the proposed 

notice, we detailed our evaluation 

criteria. Under section 1865(a)(2) of the 

Act and § 488.5, we conducted a review 

of TCT’s application in accordance with 

the criteria specified by our regulations, 

which include, but are not limited to the 

following: 

• The equivalency of TCT’s standards 

for RHCs as compared with CMS’s RHC 

conditions for certification. 

• TCT’s survey process to determine 

the following: 

++ The composition of the survey 

team, surveyor qualifications, and the 

ability of the organization to provide 

continuing surveyor training. 

++ The comparability of TCT’s 

processes to those of state agencies, 

including survey frequency, and the 

ability to investigate and respond 

appropriately to complaints against 

accredited facilities. 

++ TCT’s processes and procedures 

for monitoring a RHC determined to be 

out of compliance with TCT’s program 

requirements. These monitoring 

procedures are used only when TCT 

identifies noncompliance. If 

noncompliance is identified through 

validation reviews or complaint 

surveys, the state survey agency 

monitors corrections as specified at 

§ 488.9(c). 

++ TCT’s capacity to report 

deficiencies to the surveyed facilities 

and respond to the facility’s plan of 

correction in a timely manner. 

++ TCT’s capacity to provide CMS 

with electronic data and reports 

necessary for effective validation and 

assessment of the organization’s survey 

process. 

++ The adequacy of TCT’s staff and 

other resources, and its financial 

viability. 

++ TCT’s capacity to adequately fund 

required surveys. 

++ TCT’s policies with respect to 

whether surveys are announced or 

unannounced, to assure that surveys are 

unannounced. 

++ TCT’s agreement to provide CMS 

with a copy of the most current 

accreditation survey together with any 

other information related to the survey 

as CMS may require (including 

corrective action plans). 

IV. Analysis of and Responses to Public 

Comments on the Proposed Notice With 

Comment Period 

In accordance with section 

1865(a)(3)(A) of the Act, the January 23, 

2018 proposed notice also solicited 

public comments regarding whether 

TCT’s requirements met or exceeded the 

Medicare Condition for Certification 

(CfC) for RHCs. We received one 

comment in response to our proposed 

notice. The comment received 

expressed support for TCT’s RHC 

accreditation program. 

V. Provisions of the Final Notice 

Conditions and Survey Requirements 

We compared TCT’s RCH 

accreditation requirements and survey 

process with the Medicare CfCs at 42 

CFR part 491, the survey and 

certification process requirements of 

parts 488 and 489 and survey process as 

outlined in the State Operations Manual 

(SOM). TCT’s standards crosswalk was 

also examined to ensure that the 

appropriate CMS regulations would be 

included in citations as appropriate. 

Our review and evaluation of TCT’s 

RHC application, which was conducted 

as described in section III. of this final 

notice, yielded the following areas 

where, as of the date of this notice, TCT 

has revised its standards and 

certification processes so that its 

processes are comparable to CMS 

requirements: 

• Section 491.2(1), to update its 

standard for nurse practitioner and 

accompanying crosswalk to remove the 

duplicative language ‘‘by the currently 

certified’’. 

• Section 491.4, to address staff 

licensure compliance in its surveyor 

guidance. 

• Sections 491.7(a)(2) through (b)(3), 

to correct its crosswalk to reflect the 

correct standard reference ADM 4.0.1. 

• Section 491.8(a)(3), to update its 

standard to address the regulatory 

requirement that at least one physician 

assistant or nurse practitioner be 

employed by the clinic. 

• Sections 491.8(c)(1)(i) and 

491.9(b)(2), to correct the standard 

language to clarify the required 

membership of the group of professional 

personnel responsible for policy 

development and implementation. 

• Section 491.8(c)(2)(i), to correct 

erroneously cited CMS regulatory 

references. 

• Section 491.9(b)(4), to update its 

standard language to clarify the required 

membership of the group of professional 

personnel responsible for policy review 

annually. 

• Section 491.10(a)(1), to update its 

standards and crosswalk to explicitly 

require the RHC to maintain a clinical 

record system in addition to 

maintaining the record system in 

accordance with written policies and 

procedures. 


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29120 Federal Register / Vol. 83, No. 121 / Friday, June 22, 2018 / Notices 

• Section 491.12(c)(3)(i), to update its 

standard to include reference to RHC 

‘‘staff’’ and to delete reference to 

‘‘FQHC.’’ 

• Section 491.12(d)(1)(iv), to update 

surveyor guidance to include specific 

examples of acceptable methods for 

documenting the evaluation of the 

effectiveness of RHC staff training, and 

the demonstration of RHC staff 

knowledge and competency. 

• To clearly include frequency of 

monitoring on-going compliance as a 

required element for acceptable plan of 

corrections. 

• To clarify its Administrative Policy 

regarding removal and denial of 

accreditation. 

• To ensure each deficiency is cited 

at the appropriate level according to the 

scope and severity of the finding. 

• To ensure all provider-submitted 

plans of correction address all noncompliant practices identified on 

survey. 

• To address the inaccurate reporting 

of facility and survey data to CMS. 

• To provide evidence ensuring staff 

were educated on its policy related 

required personal file documents to be 

located on site at the RHC. 

• To provide evidence ensuring staff 

are educated on its policy related to 

deficiencies that are corrected onsite. 

• To identify patient medical records 

while protecting the patient’s identity 

during the survey event. 

B. Term of Approval 

Based on our review and observations 

described in section III of this final 

notice, we have determined that TCT’s 

rural health clinic requirements meet or 

exceed our requirements, and its survey 

processes are comparable to ours. 

Therefore, we approve TCT as a national 

accreditation organization for hospitals 

that request participation in the 

Medicare program, effective July 18, 

2018 through July 18, 2024. 

VI. 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.). 

Dated: June 11, 2018. 

Seema Verma, 

Administrator, Centers for Medicare & 

Medicaid Services. 

[FR Doc. 2018–13436 Filed 6–21–18; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–3358–PN] 

Medicare and Medicaid Programs: 

Application From the American 

Association for Accreditation of 

Ambulatory Surgery Facilities, Inc. 

(AAAASF) for Continued Approval of 

its Ambulatory Surgical Center 

Accreditation Program 

AGENCY: Centers for Medicare and 

Medicaid Services, HHS. 

ACTION: Notice with request for 

comment. 

SUMMARY: This proposed notice 

acknowledges the receipt of an 

application from the American 

Association for Accreditation of 

Ambulatory Surgery Facilities, Inc. for 

continued recognition as a national 

accrediting organization for Ambulatory 

Surgical Centers that wish to participate 

in the Medicare or Medicaid programs. 

DATES: To be assured consideration, 

comments must be received at one of 

the addresses provided below, no later 

than 5 p.m. on July 23, 2018. 

ADDRESSES: In commenting, refer to file 

code CMS–3358–PN. Because of staff 

and resource limitations, we cannot 

accept comments by facsimile (FAX) 

transmission. 

Comments, including mass comment 

submissions, must be submitted in one 

of the following three 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–3358–PN, 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–3358–PN, 

Mail Stop C4–26–05, 7500 Security 

Boulevard, Baltimore, MD 21244–1850. 

For information on viewing public 

comments, see the beginning of the 

SUPPLEMENTARY INFORMATION section. 

FOR FURTHER INFORMATION CONTACT:

Erin McCoy, (410) 786–2337. 

Monda Shaver, (410) 786–3410. 

Marie Vasbinder, (410) 786–8665. 

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 

website as soon as possible after they 

have been received: http://

www.regulations.gov. Follow the search 

instructions on that website to view 

public comments. 

I. Background 

Under the Medicare program, eligible 

beneficiaries may receive covered 

services from an Ambulatory Surgical 

Center (ASC) provided certain 

requirements are met. Section 

1832(a)(2)(F)(i) of the Social Security 

Act (the Act) establishes distinct criteria 

for facilities seeking designation as an 

ASC. Regulations concerning provider 

agreements are at 42 CFR part 489 and 

those pertaining to activities relating to 

the survey and certification of facilities 

are at 42 CFR part 488. The regulations 

at 42 CFR part 416 specify the 

conditions that an ASC must meet in 

order to participate in the Medicare 

program, the scope of covered services, 

and the conditions for Medicare 

payment for ASCs. 

Generally, to enter into an agreement, 

an ASC must first be certified by a State 

survey agency as complying with the 

conditions or requirements set forth in 

part 416 of our Medicare regulations. 

Thereafter, the ASC is subject to regular 

surveys by a State survey agency to 

determine whether it continues to meet 

these requirements. 

Section 1865(a)(1) of the Act provides 

that, if a provider entity demonstrates 

through accreditation by a Centers for 

Medicare & Medicaid Services (CMS) 

approved national accrediting 

organization (AO) that all applicable 

Medicare conditions are met or 

exceeded, we may deem those provider 

entities as having met the requirements. 

Accreditation by an AO is voluntary and 

is not required for Medicare 

participation. 

If an AO is recognized by the 

Secretary of the Department of Health 

and Human Services as having 

standards for accreditation that meet or 

exceed Medicare requirements, any 

provider entity accredited by the 

national accrediting body’s approved 

program may be deemed to meet the 

Medicare conditions. An AO applying 


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