Federal Register / Vol. 88, No. 234 / Thursday, December 7, 2023 / Notices 85291 

part 491 of CMS regulations. Thereafter, 

the RHC is subject to regular surveys by 

a State survey agency to determine 

whether it continues to meet these 

requirements. 

However, there is an alternative to 

surveys by State agencies. Section 

1865(a)(1) of the Act provides that, if a 

provider entity demonstrates through 

accreditation by an approved national 

accrediting organization (AO) that all 

applicable Medicare conditions are met 

or exceeded, we will 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 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 would be 

deemed to meet the Medicare 

conditions. A national AO applying for 

CMS approval of their accreditation 

program under 42 CFR 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 accrediting organizations are set forth 

at § 488.5. 

The Joint Commission (TJC) is 

requesting initial approval by CMS for 

its RHC program. 

II. Approval of Deeming Organization 

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

regulations at § 488.5 require that our 

findings concerning review and 

approval of a national accrediting 

organization’s requirements consider, 

among other factors, the applying 

accrediting organization’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 us 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 TJC’s request 

for initial approval for its RHC 

accreditation program. This notice also 

solicits public comment on whether 

TJC’s requirements meet or exceed the 

Medicare conditions of participation 

(CoPs) for RHCs. 

III. Evaluation of Deeming Authority 

Request 

TJC submitted all the necessary 

materials to enable us to make a 

determination concerning its request for 

continued approval of its RHC 

accreditation program. This application 

was determined to be complete on 

October 27, 2023. Under section 

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

at § 488.5 (Application and reapplication procedures for national 

accrediting organizations), our review 

and evaluation of TJC will be conducted 

in accordance with, but not necessarily 

limited to, the following factors: 

• The equivalency of TJC’s standards 

for RHCs as compared with CMS’ RHC 

CoPs. 

• TJC’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 TJC’s 

processes to those of State agencies, 

including survey frequency, and the 

ability to investigate and respond 

appropriately to complaints against 

accredited RHCs. 

++ TJC’s processes and procedures for 

monitoring RHCs found out of 

compliance with TJC’s program 

requirements. These monitoring 

procedures are used only when TJC 

identifies noncompliance. If 

noncompliance is identified through 

validation reviews or complaint 

surveys, the State survey agency 

monitors corrections as specified at 

§ 488.9(c). 

++ TJC’s capacity to report 

deficiencies to the surveyed RHCs and 

respond to the RHC’s plan of correction 

in a timely manner. 

++ TJC’s capacity to provide us with 

electronic data and reports necessary for 

effective validation and assessment of 

the organization’s survey process. 

++ The adequacy of TJC’s staff and 

other resources, and its financial 

viability. 

++ TJC’s capacity to adequately fund 

required surveys. 

++ TJC’s policies with respect to 

whether surveys are announced or 

unannounced, to assure that surveys are 

unannounced. 

++ TJC’s policies and procedures to 

avoid conflicts of interest, including the 

appearance of conflicts of interest, 

involving individuals who conduct 

surveys or participate in accreditation 

decisions. 

++ TJC’s agreement to provide us with 

a copy of the most current accreditation 

survey together with any other 

information related to the survey as we 

may require (including corrective action 

plans). 

IV. 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.). 

V. Response to 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. 

The Administrator of the Centers for 

Medicare & Medicaid Services (CMS), 

Chiquita Brooks-LaSure, having 

reviewed and approved this document, 

authorizes Trenesha Fultz-Mimms, who 

is the Federal Register Liaison, to 

electronically sign this document for 

purposes of publication in the Federal 

Register. 

Trenesha Fultz-Mimms, 

Federal Register Liaison, Centers for Medicare 

& Medicaid Services. 

[FR Doc. 2023–26805 Filed 12–6–23; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–E–2136] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; Truseltiq 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) has 


ddrumheller on DSK120RN23PROD with NOTICES1
85292 Federal Register / Vol. 88, No. 234 / Thursday, December 7, 2023 / Notices 

determined the regulatory review period 

for Truseltiq and is publishing this 

notice of that determination as required 

by law. FDA has made the 

determination because of the 

submission of an application to the 

Director of the U.S. Patent and 

Trademark Office (USPTO), Department 

of Commerce, for the extension of a 

patent which claims that human drug 

product. 

DATES: Anyone with knowledge that any 

of the dates as published (see 

SUPPLEMENTARY INFORMATION) are 

incorrect must submit either electronic 

or written comments and ask for a 

redetermination by February 5, 2024. 

Furthermore, any interested person may 

petition FDA for a determination 

regarding whether the applicant for 

extension acted with due diligence 

during the regulatory review period by 

June 4, 2024. See ‘‘Petitions’’ in the 

SUPPLEMENTARY INFORMATION section for 

more information. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. The https://

www.regulations.gov electronic filing 

system will accept comments until 

11:59 p.m. Eastern Time at the end of 

February 5, 2024. Comments received 

by mail/hand delivery/courier (for 

written/paper submissions) will be 

considered timely if they are received 

on or before that date. 

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–E–2136 for ‘‘Determination of 

Regulatory Review Period for Purposes 

of Patent Extension; TRUSELTIQ.’’ 

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 § 10.20 (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. 

FOR FURTHER INFORMATION CONTACT: 

Beverly Friedman, Office of Regulatory 

Policy, Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 51, 

Rm. 6250, Silver Spring, MD 20993, 

301–796–3600. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The Drug Price Competition and 

Patent Term Restoration Act of 1984 

(Pub. L. 98–417) and the Generic 

Animal Drug and Patent Term 

Restoration Act (Pub. L. 100–670) 

generally provide that a patent may be 

extended for a period of up to 5 years 

so long as the patented item (human 

drug or biologic product, animal drug 

product, medical device, food additive, 

or color additive) was subject to 

regulatory review by FDA before the 

item was marketed. Under these acts, a 

product’s regulatory review period 

forms the basis for determining the 

amount of extension an applicant may 

receive. 

A regulatory review period consists of 

two periods of time: a testing phase and 

an approval phase. For human drug 

products, the testing phase begins when 

the exemption to permit the clinical 

investigations of the drug becomes 

effective and runs until the approval 

phase begins. The approval phase starts 

with the initial submission of an 

application to market the human drug 

product and continues until FDA grants 

permission to market the drug product. 

Although only a portion of a regulatory 

review period may count toward the 

actual amount of extension that the 

Director of USPTO may award (for 

example, half the testing phase must be 

subtracted as well as any time that may 

have occurred before the patent was 

issued), FDA’s determination of the 

length of a regulatory review period for 

a human drug product will include all 

of the testing phase and approval phase 

as specified in 35 U.S.C. 156(g)(1)(B). 

FDA has approved for marketing the 

human drug product, Truseltiq 

(infigratinib) indicated for the treatment 

of adults with previously treated, 

unresectable locally advanced or 

metastatic cholangiocarcinoma with a 

fibroblast growth factor receptor 2 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 88, No. 234 / Thursday, December 7, 2023 / Notices 85293 

fusion or other rearrangement as 

detected by an FDA-approved test. This 

indication is approved under 

accelerated approval based on overall 

response rate and duration of response. 

Continued approval for this indication 

may be contingent upon verification and 

description of clinical benefit in 

confirmatory trial(s). Subsequent to this 

approval, the USPTO received a patent 

term restoration application for 

Truseltiq (U.S. Patent No. 8,552,002) 

from QED Therapeutics, Inc. (agent of 

Novartis AG), and the USPTO requested 

FDA’s assistance in determining this 

patent’s eligibility for patent term 

restoration. In a letter dated January 18, 

2023, FDA advised the USPTO that this 

human drug product had undergone a 

regulatory review period and that the 

approval of Truseltiq represented the 

first permitted commercial marketing or 

use of the product. Thereafter, the 

USPTO requested that FDA determine 

the product’s regulatory review period. 

II. Determination of Regulatory Review 

Period 

FDA has determined that the 

applicable regulatory review period for 

Truseltiq is 4,258 days. Of this time, 

4,016 days occurred during the testing 

phase of the regulatory review period, 

while 242 days occurred during the 

approval phase. These periods of time 

were derived from the following dates: 

1. The date an exemption under 

section 505(i) of the Federal Food, Drug, 

and Cosmetic Act (FD&C Act) (21 U.S.C. 

355(i)) became effective: October 2, 

2009. FDA has verified the applicant’s 

claim that the date the investigational 

new drug application became effective 

was on October 2, 2009. 

2. The date the application was 

initially submitted with respect to the 

human drug product under section 505 

of the FD&C Act: September 29, 2020. 

FDA has verified the applicant’s claim 

that the new drug application (NDA) for 

Truseltiq (NDA 214622) was initially 

submitted on September 29, 2020. 

3. The date the application was 

approved: May 28, 2021. FDA has 

verified the applicant’s claim that NDA 

214622 was approved on May 28, 2021. 

This determination of the regulatory 

review period establishes the maximum 

potential length of a patent extension. 

However, the USPTO applies several 

statutory limitations in its calculations 

of the actual period for patent extension. 

In its application for patent extension, 

this applicant seeks 1,516 days of patent 

term extension. 

III. Petitions 

Anyone with knowledge that any of 

the dates as published are incorrect may 

submit either electronic or written 

comments and, under 21 CFR 60.24, ask 

for a redetermination (see DATES). 

Furthermore, as specified in § 60.30 (21 

CFR 60.30), any interested person may 

petition FDA for a determination 

regarding whether the applicant for 

extension acted with due diligence 

during the regulatory review period. To 

meet its burden, the petition must 

comply with all the requirements of 

§ 60.30, including but not limited to: 

must be timely (see DATES), must be 

filed in accordance with § 10.20, must 

contain sufficient facts to merit an FDA 

investigation, and must certify that a 

true and complete copy of the petition 

has been served upon the patent 

applicant. (See H. Rept. 857, part 1, 98th 

Cong., 2d sess., pp. 41–42, 1984.) 

Petitions should be in the format 

specified in 21 CFR 10.30. 

Submit petitions electronically to 

https://www.regulations.gov at Docket 

No. FDA–2013–S–0610. Submit written 

petitions (two copies are required) to the 

Dockets Management Staff (HFA–305), 

Food and Drug Administration, 5630 

Fishers Lane, Rm. 1061, Rockville, MD 

20852. 

Dated: December 1, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–26885 Filed 12–6–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2015–D–3539] 

Interim Policy on Compounding Using 

Bulk Drug Substances Under Section 

503B of the Federal Food, Drug, and 

Cosmetic Act; 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 ‘‘Interim 

Policy on Compounding Using Bulk 

Drug Substances Under section 503B of 

the Federal Food, Drug, and Cosmetic 

Act’’ (draft guidance or 2023 503B 

Interim Policy Draft Guidance) to 

describe FDA’s interim policy regarding 

the use of bulk drug substances in 

compounding by outsourcing facilities 

while FDA develops the list of bulk 

drug substances that outsourcing 

facilities can use in compounding under 

the applicable section of the Federal 

Food, Drug, and Cosmetic Act (FD&C 

Act). This draft guidance, when 

finalized, will replace the guidance for 

industry entitled, ‘‘Interim Policy on 

Compounding Using Bulk Drug 

Substances Under section 503B of the 

Federal Food, Drug, and Cosmetic Act’’ 

issued in January 2017 (2017 503B 

Interim Policy Guidance). 

DATES: Submit either electronic or 

written comments on the draft guidance 

by January 8, 2024 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– 


ddrumheller on DSK120RN23PROD with NOTICES1