Federal Register / Vol. 87, No. 27 / Wednesday, February 9, 2022 / Notices 7473 

2021, a high Medicaid facility may 

request an exception to the prohibition 

on expansion of facility capacity more 

frequently than once every 2 years; may 

request to expand its facility capacity 

beyond 200 percent of the hospital’s 

baseline number of operating rooms, 

procedure rooms, and beds; and is not 

restricted to locating approved 

expansion capacity on the hospital’s 

main campus. 

Section 1877(i)(3)(A)(ii) of the Act 

and our regulations at § 411.362(c)(5) 

provide that individuals and entities in 

the community in which the provider 

requesting the exception is located must 

have an opportunity to provide input 

with respect to the provider’s 

application for the exception. For 

further information, we refer readers to 

the CMS website at: http://

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

Owned_Hospitals.html. As stated in our 

regulations, we will solicit community 

input on the request for an exception by 

publishing a notice of the request in the 

Federal Register. Individuals and 

entities in the hospital’s community 

will have 30 days to submit comments 

on the request. Community input must 

take the form of written comments and 

may include documentation 

demonstrating that the physician-owned 

hospital requesting the exception does 

or does not qualify as an ‘‘applicable 

hospital’’ or ‘‘high Medicaid facility,’’ as 

such terms are defined in § 411.362(c)(2) 

and (3). In the CY 2012 OPPS/ASC final 

rule, we gave examples of community 

input, such as documentation 

demonstrating that the hospital does not 

satisfy one or more of the data criteria 

or that the hospital discriminates 

against beneficiaries of Federal health 

programs; however, we noted that these 

were examples only and that we will 

not restrict the type of community input 

that may be submitted (76 FR 74522). If 

we receive timely comments from the 

community, we will notify the hospital, 

and the hospital will have 30 days after 

such notice to submit a rebuttal 

statement (§ 411.362(c)(5)). 

A request for an exception to the 

facility expansion prohibition is 

considered complete as follows: 

• If the request, any written 

comments, and any rebuttal statement 

include only filed Medicare hospital 

cost report data (Healthcare Cost Report 

Information System (‘‘HCRIS’’) data): (1) 

The end of the 30-day comment period 

if CMS receives no written comments 

from the community; or (2) the end of 

the 30-day rebuttal period if CMS 

receives written comments from the 

community, regardless of whether the 

hospital submitting the request submits 

a rebuttal statement (§ 411.362(c)(5)(i)). 

• If the request, any written 

comments, or any rebuttal statement 

include data from an external data 

source, no later than: (1) 180 days after 

the end of the 30-day comment period 

if CMS receives no written comments 

from the community; and (2) 180 days 

after the end of the 30-day rebuttal 

period if CMS receives written 

comments from the community, 

regardless of whether the hospital 

submitting the request submits a 

rebuttal statement (§ 411.362(c)(5)(ii)). 

The CMS decision to 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: Doctors Hospital at 

Renaissance, Ltd. 

Location: 5501 South McColl Road, 

Edinburg, Texas 78539 

Basis for this 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 especially 

welcome comments regarding whether 

the hospital qualifies as a high Medicaid 

facility. 

Individuals and entities wishing to 

submit comments on the hospital’s 

request should state whether or not they 

are in the community in which the 

hospital is located. We suggest that 

parties review the DATES and ADDRESSES

sections above to ensure timely 

submission of their comments. 

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 

We will consider all comments we 

receive by the date and time specified 

in the DATES section of this preamble. 

The Administrator of the Centers for 

Medicare & Medicaid Services (CMS), 

Chiquita Brooks-LaSure, 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: February 4, 2022. 

Lynette Wilson, 

Federal Register Liaison, Centers for Medicare 

& Medicaid Services. 

[FR Doc. 2022–02739 Filed 2–8–22; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–3404] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Generic Drug User 

Fee Program 

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: Submit written comments 

(including recommendations) on the 

collection of information by March 11, 

2022. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be submitted to https:// 

www.reginfo.gov/public/do/PRAMain. 

Find this particular information 

collection by selecting ‘‘Currently under 

Review—Open for Public Comments’’ or 

by using the search function. The OMB 

control number for this information 

collection is 0910–0727. Also include 

the FDA docket number found in 

brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Domini Bean, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 


lotter on DSK11XQN23PROD with NOTICES1
7474 Federal Register / Vol. 87, No. 27 / Wednesday, February 9, 2022 / Notices 

20852, 301–796–5733, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Generic Drug User Fee Program 

OMB Control Number 0910–0727— 

Revision 

This information collection supports 

implementation of FDA’s Generic Drug 

User Fee program. The Generic Drug 

User Fee Amendments (GDUFA) (Pub. 

L. 112–144, Title 111) were enacted to 

speed the delivery of safe and effective 

generic drugs to the public and reduce 

costs to industry. GDUFA authorizes 

FDA to assess user fees to fund critical 

and measurable enhancements to the 

performance of FDA’s generic drugs 

program, bringing greater predictability 

and timeliness to the review of generic 

drug applications. GDUFA is currently 

authorized through September 30, 2022, 

with reauthorization activities currently 

underway. For more information 

regarding GDUFA and ongoing 

implementation, we invite you to visit 

our website at https://www.fda.gov/ 

industry/fda-user-fee-programs/genericdrug-user-fee-amendments. 

GDUFA is based on an agreement 

negotiated by FDA and representatives 

of the generic drug industry intended to 

address continuing regulatory 

challenges. GDUFA reflects input 

received during an open process that 

includes regular public meetings, 

posting of meeting minutes, and 

consideration of comments from a 

public docket. We are revising the 

information collection to include the 

current GDUFA agreement, or ‘‘goals 

letter,’’ as reflected in the document 

‘‘GDUFA Reauthorization Performance 

Goals and Program Enhancements Fiscal 

Years 2018–2022,’’ available for 

download from our website at https:// 

www.fda.gov/media/101052/download. 

The performance goals and program 

enhancements specified in the goals 

letter apply to aspects of the generic 

drug review program that are important 

for facilitating timely access to quality, 

affordable generic medicines. FDA is 

committed to meeting the performance 

goals specified in the goals letter and to 

continuous improvement of its 

performance. 

Included among the performance 

goals is the issuance of topic-specific 

guidance documents. We maintain a 

searchable guidance database on our 

website at https://www.fda.gov/ 

regulatory-information/search-fdaguidance-documents. In publishing the 

respective notices of availability for 

each guidance document, we include an 

analysis under the PRA and invite 

public comment on the associated 

information collection 

recommendations. In addition, all 

Agency guidance documents are issued 

in accordance with our Good Guidance 

Practice regulations in 21 CFR 10.115, 

which provide for public comment at 

any time. 

We have developed Form FDA 3794, 

the Generic Drug User Fee Cover Sheet, 

available at https://www.fda.gov/ 

industry/fda-user-fee-programs which 

requests the minimum necessary 

information from generic drug 

applicants to account for and track user 

fees and to determine the amount of the 

fee required. Applicants complete and 

submit the cover sheets to accompany 

payments. While applicants may submit 

payment through multiple means, all 

cover sheets are prepared using FDA’s 

web-based electronic User Fee System. 

Upon submitting the completed cover 

sheet, the User Fee System generates a 

user fee identification number, which is 

provided to applicants at the bottom of 

the cover sheet. It also notes the correct 

fiscal year user fee assessment that is 

due for the submission or program. FDA 

requests that applicants submit a copy 

of this completed cover sheet along with 

the abbreviated new drug application, as 

well as other additional GDUFA fees, so 

FDA can verify that the applicant has 

paid the correct user fee and their 

account is current. 

Respondents to the information 

collection are potential or actual generic 

drug application holders or related 

active pharmaceutical ingredient and 

finished dosage form manufacturers. 

Companies with multiple user fee 

obligations may submit a cover sheet for 

each user fee obligation. 

In the Federal Register of November 

19, 2021 (86 FR 64945), we published a 

60-day notice requesting public 

comment on the proposed collection of 

information. No comments were 

received. 

We estimate the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1

Form FDA 3794 Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average burden 

per response Total hours 

Generic Drug User Fee Cover Sheet .......................... 500 7.616 3,808 0.5(30 minutes) ...... 1,904 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Based on a review of the information 

collection, we have retained the 

currently approved burden estimate. 

Dated: February 3, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–02689 Filed 2–8–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Allergy and 

Infectious Diseases; Notice of Closed 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Allergy and Infectious Diseases Special 

Emphasis Panel NIAID New Innovators 

Awards (DP2 Clinical Trial Not Allowed). 

Date: March 10–11, 2022. 

Time: 10:00 a.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 


lotter on DSK11XQN23PROD with NOTICES1