44416 Federal Register / Vol. 82, No. 183 / Friday, September 22, 2017 / Notices 

• Section 416.50(b), to ensure its 

standards appropriately reference Part 

420. 

• Section 488.5(a)(4)(ii), to ensure 

AOA/HFAP’s surveyors review the 

minimum number of medical records as 

specified by CMS and AOA/HFAP 

policy. 

• Section 488.5(a)(4)(iv), to ensure 

each that all observations of noncompliance are documented in the 

survey report. 

• Section 488.5(a)(7) through (9), to 

ensure AOA/HFAP complies with its 

policy and criteria for surveyor 

qualifications, education and evaluation 

system to monitor the performance of 

surveyors and teams. 

• Section 488.26(b), to ensure AOA/ 

HFAP cites findings of observed noncompliance at the appropriate level 

(condition versus standard level). 

B. Term of Approval 

Based on our review and observations 

described in section III of this final 

notice, we approve AOA/HFAP as a 

national accreditation organization for 

ASCs that request participation in the 

Medicare program, effective September 

22, 2017 through September 22, 2023. 

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.). 

Dated: September 14, 2017. 

Seema Verma, 

Administrator, Centers for Medicare & 

Medicaid Services. 

[FR Doc. 2017–20281 Filed 9–21–17; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifiers CMS–R–185, CMS– 

718–721, CMS–10123/–10124, CMS–10142, 

and CMS–R–262] 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

AGENCY: Centers for Medicare & 

Medicaid Services, HHS. 

ACTION: Notice. 

SUMMARY: The Centers for Medicare & 

Medicaid Services (CMS) is announcing 

an opportunity for the public to 

comment on CMS’ intention to collect 

information from the public. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), federal agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information (including each proposed 

extension or reinstatement of an existing 

collection of information) and to allow 

60 days for public comment on the 

proposed action. Interested persons are 

invited to send comments regarding our 

burden estimates or any other aspect of 

this collection of information, including 

the necessity and utility of the proposed 

information collection for the proper 

performance of the agency’s functions, 

the accuracy of the estimated burden, 

ways to enhance the quality, utility, and 

clarity of the information to be 

collected, and the use of automated 

collection techniques or other forms of 

information technology to minimize the 

information collection burden. 

DATES: Comments must be received by 

November 21, 2017. 

ADDRESSES: When commenting, please 

reference the document identifier or 

OMB control number. To be assured 

consideration, comments and 

recommendations must be submitted in 

any one of the following ways: 

1. Electronically. You may send your 

comments electronically to http://

www.regulations.gov. Follow the 

instructions for ‘‘Comment or 

Submission’’ or ‘‘More Search Options’’ 

to find the information collection 

document(s) that are accepting 

comments. 

2. By regular mail. You may mail 

written comments to the following 

address: CMS, Office of Strategic 

Operations and Regulatory Affairs, 

Division of Regulations Development, 

Attention: Document Identifier/OMB 

Control Number ll, Room C4–26–05, 

7500 Security Boulevard, Baltimore, 

Maryland 21244–1850. 

To obtain copies of a supporting 

statement and any related forms for the 

proposed collection(s) summarized in 

this notice, you may make your request 

using one of following: 

1. Access CMS’ Web site address at 

http://www.cms.hhs.gov/Paperwork

ReductionActof1995. 

2. Email your request, including your 

address, phone number, OMB number, 

and CMS document identifier, to 

Paperwork@cms.hhs.gov. 

3. Call the Reports Clearance Office at 

(410) 786–1326. 

FOR FURTHER INFORMATION CONTACT: 

William Parham at (410) 786–4669. 

SUPPLEMENTARY INFORMATION: 

Contents 

This notice sets out a summary of the 

use and burden associated with the 

following information collections. More 

detailed information can be found in 

each collection’s supporting statement 

and associated materials (see 

ADDRESSES). 

CMS–R–185 Granting and Withdrawal 

of Deeming Authority to Private 

Nonprofit Accreditation 

Organizations and CLIA Exemption 

under State Laboratory Programs 

CMS–718–721 Business Proposal 

Forms for Quality Improvement 

Organizations (QIOs) 

CMS–10123/–10124 Fast Track 

Appeals Notices: NOMNC/DENC 

CMS–10142 Bid Pricing Tool (BPT) for 

Medicare Advantage (MA) Plans and 

Prescription Drug Plans (PDP) 

CMS–R–262 Contract Year 2019 Plan 

Benefit Package (PBP) Software and 

Formulary Submission 

Under the PRA (44 U.S.C. 3501– 

3520), federal agencies must obtain 

approval from the Office of Management 

and Budget (OMB) for each collection of 

information they conduct or sponsor. 

The term ‘‘collection of information’’ is 

defined in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA 

requires federal agencies to publish a 

60-day notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension or reinstatement of an existing 

collection of information, before 

submitting the collection to OMB for 

approval. To comply with this 

requirement, CMS is publishing this 

notice. 

Information Collection 

1. Type of Information Collection 

Request: Extension of currently 

approved collection; Title of 

Information Collection: Granting and 

Withdrawal of Deeming Authority to 

Private Nonprofit Accreditation 

Organizations and CLIA Exemption 

Under State Laboratory Programs; Use: 

The information required is necessary to 

determine whether a private 

accreditation organization/State 

licensure program standards and 

accreditation/licensure process is at 

least equal to or more stringent than 

those of the Clinical Laboratory 

Improvement Amendments of 1988 

(CLIA). If an accreditation organization 

is approved, the laboratories that it 

Federal Register / Vol. 82, No. 183 / Friday, September 22, 2017 / Notices 44417 

accredits are ‘‘deemed’’ to meet the 

CLIA requirements based on this 

accreditation. Similarly, if a State 

licensure program is determined to have 

requirements that are equal to or more 

stringent than those of CLIA, its 

laboratories are considered to be exempt 

from CLIA certification and 

requirements. The information collected 

will be used by HHS to: Determine 

comparability/equivalency of the 

accreditation organization standards 

and policies or State licensure program 

standards and policies to those of the 

CLIA program; to ensure the continued 

comparability/equivalency of the 

standards; and to fulfill certain statutory 

reporting requirements. Form No.: 

CMS–R–185 (OMB control number: 

0938–0686); Frequency: Occasionally; 

Affected Public: Private Sector— 

Business or other for-profits and Notfor-profit institutions; Number of 

Respondents: 12; Total Annual 

Responses: 96; Total Annual Hours: 

384. (For policy questions regarding this 

collection contact Arlene Lopez at 410– 

786–6782.) 

2. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: Business 

Proposal Forms for Quality 

Improvement Organizations (QIOs); Use: 

The submission of proposal information 

by current quality improvement 

associations (QIOs) and other bidders, 

on the appropriate forms, will satisfy 

our need for meaningful, consistent, and 

verifiable data with which to evaluate 

contract proposals. We use the data 

collected on the forms associated with 

this information collection request to 

negotiate QIO contracts. We will be able 

to compare the costs reported by the 

QIOs on the cost reports to the proposed 

costs noted on the business proposal 

forms. Subsequent contract and 

modification negotiations will be based 

on historic cost data. The business 

proposal forms will be one element of 

the historical cost data from which we 

can analyze future proposed costs. In 

addition, the business proposal format 

will standardize the cost proposing and 

pricing process among all QIOs. With 

well-defined cost centers and line items, 

proposals can be compared among QIOs 

for reasonableness and appropriateness. 

Form Number: CMS–718–721 (OMB 

control number: 0938–0579); Frequency: 

Annually; Affected Public: Business or 

other for-profits and Not-for-profit 

institutions; Number of Respondents: 

20; Total Annual Responses: 20; Total 

Annual Hours: 1,000. (For policy 

questions regarding this collection 

contact Benjamin Bernstein at 410–786– 

6570.) 

3. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: Fast Track 

Appeals Notices: NOMNC/DENC; Use: 

Providers shall deliver a Notice of 

Medicare (Provider) Non-Coverage 

(NOMNC) to beneficiaries, enrollees, or 

both beneficiaries and enrollees no later 

than two days prior to the end of 

Medicare-covered services in skilled 

nursing facilities, home health agencies, 

comprehensive outpatient rehabilitation 

facilities, and hospices. Beneficiaries, 

enrollees or both beneficiaries and 

enrollees will use this information to 

determine whether they want to appeal 

the service termination to their Quality 

Improvement Organization (QIO). If the 

beneficiaries, enrollees or both 

beneficiaries decide to appeal, the 

Medicare provider or health plan will 

send the QIO and appellant a Detailed 

Explanation of Non-Coverage (DENC) 

detailing the rationale for the 

termination decision. Form Number: 

CMS–10123 and CMS–10124 (OMB 

control number: 0938–0953); Frequency: 

Occasionally; Affected Public: Private 

sector—Business or other for-profits and 

Not-for-profit institutions; Number of 

Respondents: 28,177; Total Annual 

Responses: 6,017,832; Total Annual 

Hours: 1,111,196. (For policy questions 

regarding this collection contact Janet 

Miller at 404–562–1799.) 

4. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: Bid Pricing Tool 

(BPT) for Medicare Advantage (MA) 

Plans and Prescription Drug Plans 

(PDP); Use: We require that Medicare 

Advantage organizations and 

Prescription Drug Plans complete the 

BPT as part of the annual bidding 

process. During this process, 

organizations prepare their proposed 

actuarial bid pricing for the upcoming 

contract year and submit them to us for 

review and approval. The purpose of the 

BPT is to collect the actuarial pricing 

information for each plan. The BPT 

calculates the plan’s bid, enrollee 

premiums, and payment rates. We 

publish beneficiary premium 

information using a variety of formats 

(www.medicare.gov, the Medicare & You 

handbook, Summary of Benefits 

marketing information) for the purpose 

of beneficiary education and 

enrollment. Form Number: CMS–10142 

(OMB control number: 0938–0944); 

Frequency: Yearly; Affected Public: 

Business or other for-profits and Notfor-profit institutions; Number of 

Respondents: 555; Total Annual 

Responses: 4,995; Total Annual Hours: 

149,850. (For policy questions regarding 

this collection contact Rachel Shevland 

at 410–786–3026.) 

5. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: Contract Year 

2019 Plan Benefit Package (PBP) 

Software and Formulary Submission; 

Use: We require that Medicare 

Advantage and Prescription Drug Plan 

organizations submit a completed PBP 

and formulary as part of the annual 

bidding process. During this process, 

organizations prepare their proposed 

plan benefit packages for the upcoming 

contract year and submit them to us for 

review and approval. We publish 

beneficiary education information using 

a variety of formats. The specific 

education initiatives that utilize PBP 

and formulary data include web 

application tools on www.medicare.gov 

and the plan benefit insert in the 

Medicare & You handbook. In addition, 

organizations utilize the PBP data to 

generate their Summary of Benefits 

marketing information. Form Number: 

CMS–R–262 (OMB control number 

0938–0763); Frequency: Yearly; Affected 

Public: Business or other for-profits and 

Not-for-profit institutions; Number of 

Respondents: 520; Total Annual 

Responses: 5,675; Total Annual Hours: 

54,550. (For policy questions regarding 

this collection contact Kristy Holtje at 

410–786–2209.) 

Dated: September 19, 2017. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2017–20290 Filed 9–21–17; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0275] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Certification To 

Accompany Drug, Biological Product, 

and Device Applications or 

Submissions 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the Agency. Under the