Federal Register / Vol. 85, No. 229 / Friday, November 27, 2020 / Notices 76079 

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’ website address at 

website address at https://www.cms.gov/ 

Regulations-and-Guidance/Legislation/ 

PaperworkReductionActof1995/PRAListing.html. 

2. Call the Reports Clearance Office at 

(410) 786–1326. 

FOR FURTHER INFORMATION CONTACT: 

William N. 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–10292 State Medicaid HIT Plan, 

Planning Advance Planning 

Document, and Implementation 

Advance Planning Document for 

Section 4201 of the Recovery Act 

CMS–R–65 Final Peer Review 

Organizations Sanction Regulations 

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 a currently 

approved collection; Title of 

Information Collection: State Medicaid 

HIT Plan, Planning Advance Planning 

Document, and Implementation 

Advance Planning Document for 

Section 4201 of the Recovery Act; Use: 

To assess the appropriateness of state 

requests for the administrative Federal 

financial participation for expenditures 

under their Medicaid Electronic Health 

Record Incentive Program related to 

health information exchange, our staff 

will review the submitted information 

and documentation to make an approval 

determination of the state advance 

planning document. Form Number: 

CMS–10292 (OMB control number: 

0938–1088); Frequency: Once and 

occasionally; Affected Public: State, 

Local, and Tribal Governments; Number 

of Respondents: 56; Total Annual 

Responses: 56; Total Annual Hours: 

896. (For policy questions regarding this 

collection contact Edward Dolly at 410– 

786–8554.) 

2. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: Final Peer 

Review Organizations Sanction 

Regulations; Use: The Peer Review 

Improvement Act of 1982 amended Title 

XI of the Social Security Act (the Act), 

creating the Utilization and Quality 

Control Peer Review Organization 

Program. Section 1156 of the Act 

imposes obligations on health care 

practitioners and others who furnish or 

order services or items under Medicare. 

This section also provides for sanction 

actions, if the Secretary determines that 

the obligations as stated by this section 

are not met. Quality Improvement 

Organizations (QIOs) are responsible for 

identifying violations. The QIOs may 

allow practitioners or other entities, 

opportunities to submit relevant 

information before determining that a 

violation has occurred. The information 

collection requirements contained in 

this information collection request are 

used by the QIOs to collect the 

information necessary to make their 

decision. Form Number: CMS–R–65 

(OMB control number: 0938–0444); 

Frequency: Occasionally; Affected 

Public: Private sector—Business or other 

for-profit and Not-for-profit institutions; 

Number of Respondents: 18; Total 

Annual Responses: 18; Total Annual 

Hours: 4,716. (For policy questions 

regarding this collection contact 

Kimberly Harris at 401–837–1118.) 

Dated: November 23, 2020. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2020–26223 Filed 11–25–20; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–10443, CMS– 

10558 and CMS–287–21] 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

AGENCY: Centers for Medicare & 

Medicaid Services, Health and Human 

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 

(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 

a second opportunity for public 

comment on the notice. Interested 

persons are invited to send comments 

regarding the burden estimate 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 on the collection(s) of 

information must be received by the 

OMB desk officer by December 28, 2020. 

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. 

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’ website address at 

website address at https://www.cms.gov/ 

Regulations-and-Guidance/Legislation/ 

PaperworkReductionActof1995/PRAListing.html 


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76080 Federal Register / Vol. 85, No. 229 / Friday, November 27, 2020 / Notices 

2. Call the Reports Clearance Office at 

(410) 786–1326. 

FOR FURTHER INFORMATION CONTACT: 

William Parham at (410) 786–4669. 

SUPPLEMENTARY INFORMATION: Under the 

Paperwork Reduction Act of 1995 (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 (44 U.S.C. 

3506(c)(2)(A)) requires federal agencies 

to publish a 30-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 that summarizes 

the following proposed collection(s) of 

information for public comment: 

1. Type of Information Collection 

Request: Extension of a previously 

approved collection: Title of 

Information Collection: Transcatheter 

Valve Therapy (TVT) Registry; Use: The 

data collection is required by the 

Centers for Medicare and Medicaid 

Services (CMS) National Coverage 

Determination (NCD) entitled, 

‘‘Transcatheter Aortic Valve 

Replacement (TAVR)’’. The TAVR 

device is only covered when specific 

conditions are met including that the 

heart team and hospital are submitting 

data in a prospective, national, audited 

registry. The data includes patient, 

practitioner and facility level variables 

that predict outcomes such as all cause 

mortality and quality of life. CMS finds 

that the Society of Thoracic Surgery/ 

American College of Cardiology 

Transcatheter Valve Therapy (STS/ACC 

TVT) Registry, one registry overseen by 

the National Cardiovascular Data 

Registry, meets the requirements 

specified in the NCD on TAVR. The 

TVT Registry will support a national 

surveillance system to monitor the 

safety and efficacy of the TAVR 

technologies for the treatment of aortic 

stenosis. 

The data will also include the 

variables on the eight item Kansas City 

Cardiomyopathy Questionnaire (KCCQ– 

10) to assess heath status, functioning 

and quality of life. In the KCCQ, an 

overall summary score can be derived 

from the physical function, symptoms 

(frequency and severity), social function 

and quality of life domains. For each 

domain, the validity, reproducibility, 

responsiveness and interpretability have 

been independently established. Scores 

are transformed to a range of 0–100, in 

which higher scores reflect better health 

status. 

The conduct of the STS/ACC TVT 

Registry and the KCCQ–10 is in 

accordance with Section 1142 of the 

Social Security Act (the Act) that 

describes the authority of the Agency for 

Healthcare Research and Quality 

(AHRQ). Under section 1142, research 

may be conducted and supported on the 

outcomes, effectiveness, and 

appropriateness of health care services 

and procedures to identify the manner 

in which disease, disorders, and other 

health conditions can be prevented, 

diagnosed, treated, and managed 

clinically. Section 1862(a)(1)(E) of the 

Act allows Medicare to cover under 

coverage with evidence development 

(CED) certain items or services for 

which the evidence is not adequate to 

support coverage under section 

1862(a)(1)(A) and where additional data 

gathered in the context of a clinical 

setting would further clarify the impact 

of these items and services on the health 

of beneficiaries. 

The data collected and analyzed in 

the TVT Registry will be used by CMS 

to determine if the TAVR is reasonable 

and necessary (e.g., improves health 

outcomes) for Medicare beneficiaries 

under Section 1862(a)(1)(A) of the Act. 

Furthermore, data from the Registry will 

assist the medical device industry and 

the Food and Drug Administration 

(FDA) in surveillance of the quality, 

safety and efficacy of new medical 

devices to treat aortic stenosis. For 

purposes of the TAVR NCD, The TVT 

Registry has contracted with the Data 

Analytic Centers to conduct the 

analyses. In addition, data will be made 

available for research purposes under 

the terms of a data use agreement that 

only provides de-identified datasets. 

Form Number: CMS–10443 (OMB 

control number: 0938–1202); Frequency: 

Annual; Affected Public: Individuals, 

Households and Private Sector; Number 

of Respondents: 37,221; Total Annual 

Responses: 148,884; Total Annual 

Hours: 47,765. (For policy questions 

regarding this collection contact Sarah 

Fulton at 410–786–2749.) 

2. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: Information 

Collection for Machine Readable Data 

for Provider Network and Prescription 

Formulary Content for FFM QHPs; Use: 

Under 45 CFR 156.122(d)(1)(2), 

156.230(b), and 156.230(c), and in the 

final rule, Patient Protection and 

Affordable Care Act; HHS Notice of 

Benefit and Payment Parameters for 

2018 (CMS–9934–F), standards for 

qualified health plan (QHP) issuers 

(including Small Business Health 

Options Program (SHOP) issuers and 

stand-alone dental plans (SADP) 

issuers) are established for the 

submission of provider and formulary 

data in a machine- readable format to 

the Department of Health and Human 

Services (HHS) and for posting on issuer 

websites. These standards provide 

greater transparency for consumers, 

including by allowing software 

developers to access formulary and 

provider data to create innovative and 

informative tools. The Centers for 

Medicare and Medicaid Services (CMS) 

is continuing an information collection 

request (ICR) in connection with these 

standards. Form Number: CMS–10558 

(OMB control number 0938–1284); 

Frequency: Annually; Affected Public: 

Private Sector, State, Business, and Notfor Profits; Number of Respondents: 376; 

Number of Responses: 376; Total 

Annual Hours: 10,495. (For questions 

regarding this collection, contact Joshua 

Van Drei at 410–786–1659). 

3. Type of Information Collection 

Request: Reinstatement with change of a 

previously approved collection; Title of 

Information Collection: Home Office 

Cost Statement; Use: The primary 

function of the home office cost 

statement is to provide the documentary 

support required for a Medicare 

provider to claim reimbursement for 

HO/CO costs in their Medicare cost 

report. A HO/CO must submit an 

acceptable home office cost statement 

directly to the servicing contractors for 

its providers that received a home office 

cost allocation for reimbursement 

determinations. Section 1874A of the 

Act describes the functions of the 

contractor. 

The home office cost statement 

schedules collect the cost data required 

to support home office costs claimed in 

a provider’s Medicare cost report. The 

Schedule S includes the certification 

statement where the HO/CO attests to 

the accuracy of the information and 

allows the HO/CO the opportunity to 

electronically sign and electronically 

submit the home office cost statement. 

The Schedule S–1 collects identifying 

data about the home office and key 

officers/employees of the home office. 

The Schedule S–2 collects identifying 

information for healthcare provider 

components, non-healthcare 

components, and region/division 

components of the HO/CO, and 

provides the structure for reporting 


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Federal Register / Vol. 85, No. 229 / Friday, November 27, 2020 / Notices 76081 

costs for those components throughout 

the cost statement. The A series of 

schedules collects the HO/CO trial 

balance of expenses, reclassifications, 

and adjustments, for allocation of the 

HO/CO costs to its components. On the 

B series of schedules, the home office 

directly allocates costs directly 

attributable to specific components. On 

the C and D series of schedules, the HO/ 

CO functionally allocates costs to 

components in a manner that reasonably 

relates to the services provided to the 

components. On the E series of 

schedules, the HO/CO allocates pooled 

costs (costs not directly assigned or 

functionally allocated) to the 

components. On the F series of 

schedule, the HO/CO summarizes the 

cost allocations by component. On the 

G series of schedules, the HO/CO 

reports financial data from their balance 

sheet and income statement. Form 

Number: CMS–287–21 (OMB control 

number 0938–0202); Frequency: 

Annually; Affected Public: Private 

Sector, State, Business, and Not-for 

Profits; Number of Respondents: 1,626; 

Number of Responses: 1,626; Total 

Annual Hours: 757,716. (For questions 

regarding this collection, contact Gail 

Duncan at 410–786–7278.) 

Dated: November 20, 2020. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2020–26156 Filed 11–25–20; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–N–1736] 

Potential Approach for Ranking of 

Antimicrobial Drugs According to 

Their Importance in Human Medicine: 

A Risk Management Tool for 

Antimicrobial New Animal Drugs; 

Extension of Comment Period 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public meeting and 

request for comments; extension of 

comment period. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) is 

extending the comment period for the 

notice announcing a public meeting and 

requesting comments that appeared in 

the Federal Register of October 13, 

2020. In that notice, FDA announced a 

public meeting, held on November 16, 

2020, and requested public input on a 

potential revised approach for 

considering the human medical 

importance of antimicrobial new animal 

drugs when assessing and managing the 

antimicrobial resistance risks associated 

with the use of antimicrobial drugs in 

animals. Specifically, the Agency 

requested comments on the potential 

revised process for ranking 

antimicrobials according to their 

relative importance in human medicine, 

on the potential criteria for their 

ranking, and on the resulting ranked list 

of antimicrobial drugs. FDA is taking 

this action in response to several 

requests for extension to allow 

interested persons additional time to 

submit comments. 

DATES: FDA is extending the comment 

period announced in the notice of 

public meeting and request for 

comments published October 13, 2020 

(85 FR 64481). Submit either electronic 

or written comments by March 16, 2021, 

to ensure that the Agency considers 

your comments regarding this public 

meeting and request for comments. 

ADDRESSES: You may submit comments 

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– 

2020–N–1736 for ‘‘Potential Approach 

for Ranking of Antimicrobial Drugs 

According to Their Importance in 

Human Medicine: A Risk Management 

Tool for Antimicrobial New Animal 

Drugs.’’ Received comments, those filed 

in a timely manner (see ADDRESSES), 

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 between 9 

a.m. and 4 p.m., Monday through 

Friday, 240–402–7500. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://

www.govinfo.gov/content/pkg/FR-2015- 

09-18/pdf/2015-23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 


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