35486 Federal Register / Vol. 83, No. 144 / Thursday, July 26, 2018 / Notices 

• Background 

• Online Public Meeting 

• Instructions 

DATES: The online meeting will be held 

September 13, 2018 from 1 p.m.–4 p.m., 

Eastern Time, or until the last public 

presenter has spoken, whichever occurs 

first. The public online meeting will be 

a web-based event available only by 

remote access. Members of the public 

who wish to provide public comments 

should plan to log in to the meeting at 

the start time listed. Members of the 

public who register with the NIOSH 

Docket Office, niocindocket@cdc.gov, to 

attend the public meeting will be 

provided the login information prior to 

the meeting. 

ADDRESSES: Written comments 

submitted to the docket must be 

received by October 15, 2018. Written 

comments may be submitted by any of 

the following two methods: 

• Federal eRulemaking Portal: 

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

instructions for submitting comments. 

• Mail: NIOSH Docket Office, 1090 

Tusculum Ave., MS C–34, Cincinnati, 

Ohio 45226–1998. 

FOR FURTHER INFORMATION CONTACT: 

Doug Daniels, Education and 

Information Division/NIOSH, 1090 

Tusculum Avenue, Cincinnati, OH 

45226–1998, telephone (513) 533–8329 

(not a toll free number). 

SUPPLEMENTARY INFORMATION: 

Background: The proposed NIOSH 

document describes the underlying 

science and general approach used by 

NIOSH researchers when conducting 

high quality, scientifically sound 

assessments of the health risk associated 

with workplace hazards. The report 

focuses on chemical risk assessment 

practices; however, some of these 

practices may also benefit assessments 

of other workplace hazards, such as 

traumatic injury or work stress. Risk 

assessments are an important tool for 

informed decision-making on workplace 

safeguards; therefore, these assessments 

have supported NIOSH 

recommendations on limiting chemical 

exposures. The information provided by 

the proposed NIOSH document is 

intended for NIOSH risk assessors, other 

scientists, stakeholders, and the public 

to improve their understanding of the 

NIOSH risk assessment process. 

The purpose of the public review of 

the draft document is to obtain 

comments on whether the proposed 

NIOSH draft document (1) adequately, 

clearly, and concisely explains NIOSH 

practices in risk assessment; and (2) 

demonstrates that its practices are 

consistent with the current scientific 

knowledge. 

Purpose of Meeting 

To discuss and obtain comments on 

the draft document, Current Intelligence 

Bulletin: NIOSH Practices in 

Occupational Risk Assessment. Special 

emphasis will be placed on discussion 

of the following questions for reviewers: 

(1) Are the methods presented in the 

proposed NIOSH document consistent 

with the current scientific knowledge of 

toxicology, epidemiology, industrial 

hygiene, and risk assessment? If not, 

provide specific information and 

references that should be considered. 

(2) Is there additional scientific 

information related to the issues of the 

proposed NIOSH document that should 

be considered for inclusion? If so, 

provide information and specify 

references for consideration. Is there any 

discussion in the document that should 

be omitted? 

(3) Is information in the proposed 

NIOSH document explained in a clear 

and transparent manner? If not, specify 

(section, page, and line number) where 

clarification is needed. 

Online Public Meeting 

The meeting is open to the public, 

limited only by the number of logins 

available. The Adobe Connect license 

accommodates approximately 500 

people. In addition, there will be an 

audio conference for those who cannot 

log in through a computer. There is no 

registration fee to attend this public 

online meeting. However, those wishing 

to attend are encouraged to register via 

email to NIOSH Docket Office 

niocindocket@cdc.gov by September 6, 

2018. Registrants will be provided with 

the public meeting login information 

prior to the meeting. Individuals 

wishing to speak during the meeting 

may sign up when registering. Those 

who have not signed up to present in 

advance may be allowed to present at 

the meeting if time allows. Persons 

wanting to provide oral comments will 

be permitted up to 20 minutes. If 

additional time becomes available, 

presenters will be notified. Oral 

comments given at the meeting must 

also be submitted to the docket in 

writing in order to be considered by the 

Agency. Priority for attendance will be 

given to those providing oral comments. 

Other requests to attend the meeting 

will then be accommodated on a firstcome basis. Unreserved attendees will 

be admitted as login space allows. 

Instructions: All material submitted to 

the Agency should reference the agency 

name and docket number [CDC–2018– 

0060; NIOSH–316]. Each person making 

a comment will be asked to give his or 

her name and affiliation, and all 

comments (including their name and 

affiliation) will be posted without 

change to https://www.regulations.gov. 

All information received in response to 

this notice will be available for public 

examination and copying at the NIOSH 

Docket Office, Room 155, 1150 

Tusculum Parkway, Cincinnati, Ohio 

45226–1998. 

Dated: July 23, 2018. 

Frank J. Hearl, 

Chief of Staff, National Institute for 

Occupational Safety and Health, Centers for 

Disease Control and Prevention. 

[FR Doc. 2018–15967 Filed 7–25–18; 8:45 am] 

BILLING CODE 4163–19–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–3362–PN] 

Medicare and Medicaid Programs: 

Application From the Accreditation 

Association for Ambulatory Health 

Care, Inc. (AAAHC) for Continued 

Approval of Its Ambulatory Surgical 

Center Accreditation Program 

AGENCY: Centers for Medicare and 

Medicaid Services (CMS), HHS. 

ACTION: Notice with request for 

comment. 

SUMMARY: This proposed notice 

acknowledges the receipt of an 

application from the Accreditation 

Association for Ambulatory Health Care, 

Inc. (AAAHC) for continued recognition 

as a national accrediting organization 

(AO) for Ambulatory Surgical Centers 

(ASCs) 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 August 27, 2018. 

ADDRESSES: In commenting, refer to file 

code CMS–3362–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: 


sradovich on DSK3GMQ082PROD with NOTICES
Federal Register / Vol. 83, No. 144 / Thursday, July 26, 2018 / Notices 35487 

CMS–3362–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–3362–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, or 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 

for approval of its accreditation program 

under part 488, subpart A, must provide 

CMS with reasonable assurance that the 

AO requires the accredited provider 

entities to meet requirements that are at 

least as stringent as the Medicare 

conditions. Our regulations concerning 

the approval of AOs are set forth at 

§ 488.5. 

The Accreditation Association for 

Ambulatory Health Care, Inc.’s 

(AAAHC’s) current term of approval for 

its ASC program expires December 20, 

2018. 

II. Provisions of the Proposed Notice 

A. Approval of Deeming Organizations 

Section 1865(a)(2) of the Act and our 

regulations at § 488.5 require that our 

findings concerning review and 

approval of an AO’s requirements 

consider, among other factors, the 

applying AO’s requirements for 

accreditation; survey procedures; 

resources for conducting required 

surveys; capacity to furnish information 

for use in enforcement activities; 

monitoring procedures for provider 

entities found not in compliance with 

the conditions or requirements; and 

ability to provide CMS with the 

necessary data for validation. 

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

further requires that we publish, within 

60 days of receipt of an organization’s 

complete application, a notice 

identifying the national accrediting 

body making the request, describing the 

nature of the request, and providing at 

least a 30-day public comment period. 

We have 210 days from the receipt of a 

complete application to publish notice 

of approval or denial of the application. 

The purpose of this proposed notice 

is to inform the public of AAAHC’s 

request for continued CMS-approval of 

its ASC accreditation program. This 

notice also solicits public comment on 

whether AAAHC’s requirements meet or 

exceed the Medicare conditions for 

coverage (CfCs) for ASCs. 

B. Evaluation of Deeming Authority 

Request 

AAAHC submitted all the necessary 

materials to enable us to make a 

determination concerning its request for 

continued CMS-approval of its ASC 

accreditation program. This application 

was determined to be complete on May 

24, 2018. Under section 1865(a)(2) of the 

Act and our regulations at § 488.5, our 

review and evaluation of AAAHC will 

be conducted in accordance with, but 

not necessarily limited to, the following 

factors: 

• The equivalency of AAAHC’s 

standards for ASCs as compared with 

Medicare’s CfCs for ASCs. 

• AAAHC’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 AAAHC’s 

processes to those of State agencies, 

including survey frequency, and the 

ability to investigate and respond 

appropriately to complaints against 

accredited facilities. 

++ AAAHC’s processes and 

procedures for monitoring an ASC 

found out of compliance with AAAHC’s 

program requirements. These 

monitoring procedures are used only 

when AAAHC identifies 

noncompliance. If noncompliance is 

identified through validation reviews or 

complaint surveys, the State survey 

agency monitors corrections as specified 

at § 488.9(c)(1). 

++ AAAHC’s capacity to report 

deficiencies to the surveyed facilities 

and respond to the facility’s plan of 

correction in a timely manner. 

++ AAAHC’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 AAAHC’s staff 

and other resources, and its financial 

viability. 

++ AAAHC’s capacity to adequately 

fund required surveys. 

++ AAAHC’s policies with respect to 

whether surveys are announced or 

unannounced, to assure that surveys are 

unannounced. 

++ AAAHC’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). 


sradovich on DSK3GMQ082PROD with NOTICES
35488 Federal Register / Vol. 83, No. 144 / Thursday, July 26, 2018 / Notices 

C. Notice Upon Completion of 

Evaluation 

Upon completion of our evaluation, 

including evaluation of public 

comments received as a result of this 

notice, we will publish a final notice in 

the Federal Register announcing the 

result of our evaluation. 

III. 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.). 

IV. Response to Public 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. 

Dated: July 20, 2018. 

Seema Verma, 

Administrator, Centers for Medicare & 

Medicaid Services. 

[FR Doc. 2018–15951 Filed 7–23–18; 4:15 pm] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Proposed Information Collection 

Activity; Comment Request 

Proposed Projects: 

Title: National Youth in Transition 

Database (NYTD) and Youth Outcomes 

Survey. 

OMB No.: 0970–0340. 

Description: The John H. Chafee 

Foster Care Program for Successful 

Transition to Adulthood (42 U.S.C. 677, 

as amended by Pub. L. 115–123, the 

Family First Prevention Services Act 

within Division E, Title VII of the 

Bipartisan Budget Act of 2018) requires 

State child welfare agencies to collect 

and report to the Administration for 

Children and Families (ACF) data on the 

characteristics of youth receiving 

independent living services and 

information regarding their outcomes. 

The regulation implementing the 

National Youth in Transition Database 

(NYTD), listed in 45 CFR 1356.80, 

contains standard data collection and 

reporting requirements for States to 

meet the law’s requirements. ACF uses 

the information collected under the 

regulation to track independent living 

services, assess the collective outcomes 

of youth, and assess performance with 

regard to those outcomes, consistent 

with the law’s mandate. 

Respondents: State agencies 

(including agencies of the District of 

Columbia, Puerto Rico and the U.S. 

Virgin Islands) that administer the John 

H. Chafee Foster Care Program for 

Successful Transition to Adulthood. 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden 

hours per 

response 

Total burden 

hours 

Youth Outcome Survey ................................................................................... 21,064 1 0.50 10,529 

Data File .......................................................................................................... 53 2 1,849 195,994 

Estimated Total Annual Burden 

Hours: 206,253. 

In compliance with the requirements 

of the Paperwork Reduction Act of 1995 

(Pub. L. 104–13, 44 U.S.C. Chap 35), the 

Administration for Children and 

Families is soliciting public comment 

on the specific aspects of the 

information collection described above. 

Copies of the proposed collection of 

information can be obtained and 

comments may be forwarded by writing 

to the Administration for Children and 

Families, Office of Planning, Research 

and Evaluation, 330 C Street SW, 

Washington, DC 20201. Attn: ACF 

Reports Clearance Officer. Email 

address: infocollection@acf.hhs.gov. All 

requests should be identified by the title 

of the information collection. 

The Department specifically requests 

comments on: (a) Whether the proposed 

collection of information is necessary 

for the proper performance of the 

functions of the agency, including 

whether the information shall have 

practical utility; (b) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information; (c) 

the quality, utility, and clarity of the 

information to be collected; and (d) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques or 

other forms of information technology. 

Consideration will be given to 

comments and suggestions submitted 

within 60 days of this publication. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 2018–15989 Filed 7–25–18; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–1011] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Permanent 

Discontinuation or Interruption in 

Manufacturing of Certain Drug and 

Biological Products 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by August 27, 

2018. 


sradovich on DSK3GMQ082PROD with NOTICES