Federal Register / Vol. 87, No. 83 / Friday, April 29, 2022 / Notices 25489 

Supporting Regulations; Type of 

Information Collection Request: 

Revision with change of a currently 

approved collection; Use: The 

transitional pass-through provision 

provides a way for ensuring appropriate 

payment for new technologies whose 

use and costs are not adequately 

represented in the base year claims data 

on which the outpatient PPS is 

constructed as required by law. 

Categories of medical devices will 

receive transitional pass-through 

payments for 2 to 3 years from the date 

payments are initiated for the category. 

However, the underlying provision is 

permanent and provides an on-going 

mechanism for reflecting timely 

introduction of new items into the 

payment structure. 

Interested parties such as hospitals, 

device manufacturers, pharmaceutical 

companies, and physicians apply for 

transitional pass-through payment for 

certain items used with services covered 

in the outpatient PPS. After we receive 

all requested information, we evaluate 

the information to determine if the 

creation of an additional category of 

medical devices for transitional passthrough payments is justified. We may 

request additional information related to 

the proposed new device category, as 

needed. We advise the applicant of our 

decision, and update the outpatient PPS 

during its next scheduled quarterly 

payment update cycle to reflect any 

newly approved device categories. We 

list below the information that we 

require from all applicants. The 

following information is required to 

process requests for additional 

categories of medical devices for 

transitional pass-through payments. 

Form Number: CMS–10052 (OMB 

control number: 0938–0857); Frequency: 

Annually; Affected Public: Private 

Sector, Business or other for-profits; 

Number of Respondents: 10; Number of 

Responses: 10; Total Annual Hours: 

160. (For questions regarding this 

collection contact Kimberly A. 

Campbell at 410–786–2289.) 

Dated: April 25, 2022. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2022–09167 Filed 4–28–22; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifiers: CMS–10631] 

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 May 31, 2022. 

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-andGuidance/Legislation/Paperwork

ReductionActof1995/PRA-Listing.html. 

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: Revision of a currently 

approved collection; Title of 

Information Collection: The PACE 

Organization Application Process in 42 

CFR part 460; Use: The Programs of AllInclusive Care for the Elderly (PACE) 

consist of pre-paid, capitated plans that 

provide comprehensive health care 

services to frail, older adults in the 

community who are eligible for nursing 

home care according to State standards. 

PACE organizations (PO) must provide 

all Medicare and Medicaid covered 

services; financing of this model is 

accomplished through prospective 

capitation of both Medicare and 

Medicaid payments. Upon approval of a 

PACE application, CMS executes a 

3-way program agreement with the 

applicant entity and the applicable State 

Administering Agency (SAA). CMS 

regulations at 42 CFR 460.98(b)(2) 

require a PO to provide PACE services 

in at least the PACE center, the home, 

and inpatient facilities. The PACE 

center is the focal point for the delivery 

of PACE services; the center is where 

the interdisciplinary team (IDT) is 

located, services are provided, and 

socialization occurs with staff that is 

consistent and familiar to participants. 

Collection of this information is 

mandated by statute under sections 

1894(f) and 1934(f) of the Act and at 42 

CFR part 460, subpart B, which 

addresses the PO application and 

waiver process. In general, PACE 

services are provided through a PO. An 

entity wishing to become a PO must 


lotter on DSK11XQN23PROD with NOTICES1
25490 Federal Register / Vol. 87, No. 83 / Friday, April 29, 2022 / Notices 

submit an application to CMS that 

describes how the entity meets all the 

requirements in the PACE program. An 

entity’s application must be 

accompanied by an assurance from the 

SAA of the State in which the PO 

wishes to operate its PACE program. 

CMS accepts applications on a 

designated date four times per year (i.e., 

on a quarterly basis, generally the last 

Friday of March, June, September and 

December). Form Number: CMS–10631 

(OMB control number: 0938–1326); 

Frequency: Occasionally; Affected 

Public: Private Sector, State, Local or 

Tribal governments, Business or other 

for-profits; Number of Respondents: 72; 

Total Annual Responses: 130; Total 

Annual Hours: 7,271. (For policy 

questions regarding this collection 

contact Debbie Vanhoven at 410–786– 

6625.) 

Dated: April 25, 2022. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2022–09164 Filed 4–28–22; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–D–0140] 

Ulcerative Colitis: Developing Drugs 

for Treatment; Draft Guidance for 

Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a draft 

guidance for industry entitled 

‘‘Ulcerative Colitis: Developing Drugs 

for Treatment.’’ This draft guidance 

addresses FDA’s current thinking about 

necessary attributes of clinical trials for 

developing drugs for the treatment of 

ulcerative colitis in adults, including 

recommendations for trial population, 

trial design, and efficacy and safety 

considerations. This draft guidance 

replaces the draft guidance for industry 

entitled ‘‘Ulcerative Colitis: Clinical 

Trial Endpoints,’’ which is being 

withdrawn. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by June 28, 2022 to ensure that the 

Agency considers your comment on this 

draft guidance before it begins work on 

the final version of the guidance. 

ADDRESSES: You may submit comments 

on any guidance at any time 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– 

2022–D–0140 for ‘‘Ulcerative Colitis: 

Developing Drugs for Treatment.’’ 

Received comments 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 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

Submit written requests for single 

copies of the draft guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10001 New 

Hampshire Ave., Hillandale Building, 

4th Floor, Silver Spring, MD 20993– 

0002, or the Office of Communication, 

Outreach and Development, Center for 

Biologics Evaluation and Research, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 71, Rm. 

3128, Silver Spring, MD 20993–0002. 

Send one self-addressed adhesive label 

to assist that office in processing your 

requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the draft guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Kelly Richards, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, Rm. 5378, 

Silver Spring, MD 20993, 240–402– 

4276, or Stephen Ripley, Center for 


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