73098 Federal Register / Vol. 89, No. 174 / Monday, September 9, 2024 / Notices 

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 October 9, 2024. 

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, please access the CMS PRA 

website by copying and pasting the 

following web address into your web 

browser: https://www.cms.gov/ 

Regulations-and-Guidance/Legislation/ 

PaperworkReductionActof1995/PRAListing. 

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 currently 

approved collection; Title of 

Information Collection: Hospice Facility 

Cost Report Form; Use: Under the 

authority of sections 1815(a) and 1833(e) 

of the Social Security Act (the Act), 

CMS requires that providers of services 

participating in the Medicare program 

submit information to determine costs 

for health care services rendered to 

Medicare beneficiaries. CMS requires 

that providers follow reasonable cost 

principles under 1861(v)(1)(A) of the 

Act when completing the Medicare cost 

report (MCR). The regulations at 42 CFR 

413.20 and 413.24 require that providers 

submit acceptable cost reports on an 

annual basis and maintain sufficient 

financial records and statistical data, 

capable of verification by qualified 

auditors. In addition, regulations require 

that providers furnish such Information 

to the contractor as may be necessary to 

assure proper payment by the program, 

receive program payments, and satisfy 

program overpayment determinations. 

CMS regulations at 42 CFR 

413.24(f)(4) require that each hospice 

submit an annual cost report to their 

contractor in a standard American 

Standard Code for Information 

Interchange (ASCII) electronic cost 

report (ECR) format. A hospice submits 

the ECR file to contractors using a 

compact disk (CD), flash drive, or the 

CMS approved Medicare Cost Report Efiling (MCREF) portal, [URL: https://

mcref.cms.gov]. The instructions for 

submission are included in the hospice 

cost report instructions on page 43–3. 

CMS requires the Form CMS–1984–14 

to determine a hospice’s reasonable 

costs incurred in furnishing medical 

services to Medicare beneficiaries. CMS 

uses the Form CMS–1984–14 for rate 

setting; payment refinement activities, 

including developing a market basket; 

Medicare Trust Fund projections; and 

program operations support. 

Additionally, the Medicare Payment 

Advisory Commission (MedPAC) uses 

the hospice cost report data to calculate 

Medicare margins (a measure of the 

relationship between Medicare’s 

payments and providers’ Medicare 

costs) and analyze data to formulate 

Medicare Program recommendations to 

Congress. Form Number: CMS–1984–14 

(OMB control number: 0938–0758); 

Frequency: Yearly; Affected Public: 

Private Sector, Business or other forprofits, Not for profits institutions; 

Number of Respondents: 6,430; Total 

Annual Responses: 6,430; Total Annual 

Hours: 1,208,840. (For policy questions 

regarding this collection contact Duncan 

Gail at 410–786–7278.) 

2. Type of Information Collection: 

Extension of a currently approved 

collection; Title of Information 

Collection: Organ Procurement 

Organization Histocompatibility 

Laboratory Cost Report; Use: The Form 

CMS–216–94 cost report is needed to 

determine Organ Procurement 

Organization (OPO)/Histocompatibility 

Lab (HL) reasonable costs incurred in 

procuring and transporting organs for 

transplant into Medicare beneficiaries 

and reimbursement due to or from the 

provider. The reasonable costs of 

procuring and transporting organs 

cannot be determined for the fiscal year 

until the OPO/HL files its cost report 

and costs are verified by the Medicare 

contractor. During the fiscal year, an 

interim rate is established based on cost 

report data from the previous year. The 

OPO/HL bills the transplant hospital for 

services rendered. The transplant 

hospital pays interim payments, 

approximating reasonable cost, to the 

OPO/HL. The Form CMS–216–94 cost 

report is filed by each OPO/HL at the 

end of its fiscal year and there is a cost 

report settlement to take into account 

increases or decreases in costs. The cost 

report reconciliation and settlement take 

into consideration the difference 

between the total reasonable costs 

minus the total interim payments 

received or receivable from the 

transplant centers. Form Number: CMS– 

216–94 (OMB control number: 0938– 

0102); Frequency: Annually; Affected 

Public: Private Sector—Business or 

other for-profits; Number of 

Respondents: 95; Total Annual 

Responses: 95; Total Annual Hours: 

4,275. (For policy questions regarding 

this collection contact Luann Piccione 

at 410–786–5423.) 

William N. Parham, III, 

Director, Division of Information Collections 

and Regulatory Impacts, Office of Strategic 

Operations and Regulatory Affairs. 

[FR Doc. 2024–20236 Filed 9–6–24; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–E–2484] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; PLUVICTO 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) has 

determined the regulatory review period 

for PLUVICTO and is publishing this 

notice of that determination as required 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 89, No. 174 / Monday, September 9, 2024 / Notices 73099 

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 may submit either electronic 

or written comments and ask for a 

redetermination by November 8, 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 

March 10, 2025. 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 

November 8, 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– 

2023–E–2484 for ‘‘Determination of 

Regulatory Review Period for Purposes 

of Patent Extension; PLUVICTO.’’ 

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. 6200, 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 biological 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, PLUVICTO 

(lutetium Lu 177 vipivotide tetraxetan) 

indicated for the treatment of adult 

patients with prostate-specific 

membrane antigen-positive metastatic 

castration-resistant prostate cancer who 

have been treated with androgen 

receptor pathway inhibition and taxaneVerDate Sep<11>2014 17:19 Sep 06, 2024 Jkt 262001 PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 E:\FR\FM\09SEN1.SGM 09SEN1

ddrumheller on DSK120RN23PROD with NOTICES1
73100 Federal Register / Vol. 89, No. 174 / Monday, September 9, 2024 / Notices 

based chemotherapy. Subsequent to this 

approval, the USPTO received a patent 

term restoration application for 

PLUVICTO (U.S. Patent No. 10,398,791) 

from Advanced Accelerator 

Applications USA, Inc. (Agent of 

Deutsches Krebsforschungszentrum & 

Ruprecht-Karls-Universitat Heidelberg) 

and the USPTO requested FDA’s 

assistance in determining the patent’s 

eligibility for patent term restoration. In 

a letter dated October 19, 2023, FDA 

advised the USPTO that this human 

drug product had undergone a 

regulatory review period and that the 

approval of PLUVICTO 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 

PLUVICTO is 1,881 days. Of this time, 

1,643 days occurred during the testing 

phase of the regulatory review period, 

while 238 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: January 29, 

2017. FDA has verified the applicant’s 

claim that the date the investigational 

new drug application became effective 

was on January 29, 2017. 

2. The date the application was 

initially submitted with respect to the 

human drug product under section 505 

of the FD&C Act: July 29, 2021. FDA has 

verified the applicant’s claim that the 

new drug application (NDA) for 

PLUVICTO (NDA 215833) was initially 

submitted on July 29, 2021. 

3. The date the application was 

approved: March 23, 2022. FDA has 

verified the applicant’s claim that NDA 

215833 was approved on March 23, 

2022. 

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 523 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: September 4, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–20246 Filed 9–6–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Announcement of the President’s 

Advisory Commission on Asian 

Americans, Native Hawaiians, and 

Pacific Islanders Meeting and 

Solicitation for Oral and Written 

Comments Regarding Activities To 

Support the Advancement of Equity, 

Justice, and Opportunity for Asian 

American, Native Hawaiian, and Pacific 

Islander Communities. 

AGENCY: Department of Health and 

Human Services, Office of the Secretary, 

Office of Intergovernmental and 

External Affairs, White House Initiative 

on Asian Americans, Native Hawaiians, 

and Pacific Islanders. 

ACTION: Notice of meeting and 

solicitation for written and oral 

comments. 

SUMMARY: The U.S. Department of 

Health and Human Services (HHS) 

announces the tenth public meeting of 

the President’s Advisory Commission 

on Asian Americans, Native Hawaiians, 

and Pacific Islanders (Commission) and 

the solicitation of written and oral 

comment regarding the advancement of 

equity, justice, and opportunity for 

Asian American, Native Hawaiian, and 

Pacific Islander (AA and NHPI) 

communities. The meeting is open to 

the public and will be held in 

Washington, District of Columbia. 

Virtual attendance will be available 

through livestream on September 23, 

2024. The Commission will also host an 

in-person, public listening session on 

September 26, 2024, at the U.S. 

Department of Transportation 

Headquarters Building in Washington, 

District of Columbia. The Commission is 

working to accomplish its mission to 

provide independent advice and 

recommendations to the President on 

ways to advance equity, justice, and 

opportunity for AA and NHPI 

communities. 

DATES: The Commission will meet on 

September 23, 2024, from 9:15 a.m. 

Eastern Time (ET) to 4 p.m. ET. The 

final location and agenda will be posted 

on the website for the President’s 

Advisory Commission on Asian 

Americans, Native Hawaiians, and 

Pacific Islanders: https://www.hhs.gov/ 

about/whiaanhpi/commission/ 

index.html when this information 

becomes available. On September 26, 

2024, the Commission will also host an 

in-person listening session from 11:20 

a.m. Eastern Time (ET) to 12:10 p.m. ET 

during the White House Initiative on 

Asian Americans, Native Hawaiians, 

and Pacific Islanders (WHIAANHPI) 

Policy Summit in Washington, District 

of Columbia. 

ADDRESSES: Members of the public may 

attend the meeting on September 23, 

2024, virtually. Members of the public 

may attend the listening session on 

September 26, 2024, in-person. 

Registration is required through the 

following links: 

September 23 meeting (virtual 

attendance only): https://www.event

brite.com/e/meeting-of-the-presidentsadvisory-commission-on-aa-andnhpis-tickets-942107116747 

September 26 listening session (inperson attendance only): https://

www.eventbrite.com/e/white-houseaa-nhpi-policy-summit-tickets942113816787 

FOR FURTHER INFORMATION CONTACT: 

Judith Teruya, Lead Designated Federal 

Officer, President’s Advisory 

Commission on Asian Americans, 

Native Hawaiians, and Pacific Islanders, 

U.S. Department of Health and Human 

Services, Office of the Secretary, Office 

of Intergovernmental and External 

Affairs, U.S. Department of Health and 

Human Services, Hubert Humphrey 

Building, 620E, 200 Independence Ave. 

SW, Washington, DC 20201; email: 

AANHPICommission@hhs.gov; 

telephone: (240) 856–3034. 

SUPPLEMENTARY INFORMATION: 


ddrumheller on DSK120RN23PROD with NOTICES1