Federal Register / Vol. 88, No. 228 / Wednesday, November 29, 2023 / Notices 83419 

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, Empaveli 

(pegcetacoplan) indicated for the 

treatment of adult patients with 

paroxysmal nocturnal hemoglobinuria. 

Subsequent to this approval, the USPTO 

received patent term restoration 

applications for Empaveli (U.S. Patent 

Nos. 10,035,822; 10,125,171; and 

10,875,893) from Apellis 

Pharmaceuticals, Inc., and the USPTO 

requested FDA’s assistance in 

determining the patents’ eligibility for 

patent term restoration. In a letter dated 

September 21, 2022, FDA advised the 

USPTO that this human drug product 

had undergone a regulatory review 

period and that the approval of 

Empaveli 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 

Empaveli is 2,501 days. Of this time, 

2,258 days occurred during the testing 

phase of the regulatory review period, 

while 243 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: July 11, 2014. 

FDA has verified the applicant’s claim 

that the date the investigational new 

drug application became effective was 

on July 11, 2014. 

2. The date the application was 

initially submitted with respect to the 

human drug product under section 505 

of the FD&C Act: September 14, 2020. 

FDA has verified the applicant’s claim 

that the new drug application (NDA) for 

Empaveli (NDA 215014) was initially 

submitted on September 14, 2020. 

3. The date the application was 

approved: May 14, 2021. FDA has 

verified the applicant’s claim that NDA 

215014 was approved on May 14, 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 applications for patent extension, 

this applicant seeks 137 days, 545 days, 

or 579 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: November 24, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–26255 Filed 11–28–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Submission to OMB for 

Review and Approval; Public Comment 

Request; Evidence Based Telehealth 

Network Program Measures 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Notice. 

SUMMARY: In compliance with the 

Paperwork Reduction Act of 1995, 

HRSA submitted an Information 

Collection Request (ICR) to the Office of 

Management and Budget (OMB) for 

review and approval. Comments 

submitted during the first public review 

of this ICR will be provided to OMB. 

OMB will accept further comments from 

the public during the review and 

approval period. OMB may act on 

HRSA’s ICR only after the 30-day 

comment period for this notice has 

closed. 

DATES: Comments on this ICR should be 

received no later than December 29, 

2023. 

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 information 

collection by selecting ‘‘Currently under 

Review—Open for Public Comments’’ or 

by using the search function. 

FOR FURTHER INFORMATION CONTACT: To 

request a copy of the clearance requests 

submitted to OMB for review, email 

Joella Roland, the HRSA Information 

Collection Clearance Officer, at 

paperwork@hrsa.gov or call (301) 443– 

3983. 

SUPPLEMENTARY INFORMATION: 

Information Collection Request Title: 

Evidence Based Telehealth Network 

Program Measures, OMB No. 0906– 

0043—Revision. 

Abstract: This ICR is for a revision of 

a currently approved information 

collection of measures for the Office for 

the Advancement of Telehealth’s (OAT) 

Evidence Based Telehealth Network 

Program, under which OAT administers 

cooperative agreements in accordance 

with section 330I of the Public Health 

Service Act (42 U.S.C. 254c–14), as 

amended. The purpose of this program 

is to fund evidence-based projects that 

utilize telehealth technologies through 

telehealth networks to expand access to, 

and improve access to and the quality 

of, health care services. This program 

will work to help assess the 

effectiveness of evidence-based 

practices with the use of telehealth for 

patients, providers, and payers. 

In the Evidence-Based Telehealth 

Network Program Report, the adjusted 

data collection instrument includes the 

addition, removal, and revision of 

measures, with 27 total data elements 

addressing patient encounter 

information. The current measures focus 

on behavioral health and the proposed 

adjusted measures allow for the 

inclusion of broader health care services 

and expanded outcome measures. Five 

data elements were updated to specify 

data collection that allows for deeper 

understanding of outcomes related to 

socioeconomic indicators. The 

estimated burden for the EvidenceBased Telehealth Network Program 


ddrumheller on DSK120RN23PROD with NOTICES1
83420 Federal Register / Vol. 88, No. 228 / Wednesday, November 29, 2023 / Notices 

Report has decreased since the data 

collection frequency is changing from 

monthly to quarterly. In addition, the 

information collected from grantees in 

the Performance Improvement and 

Measurement System more closely 

aligns measures with the Notice of 

Funding Opportunity and will assist in 

clarifying program measures and 

impact. These adjustments allow OAT 

to gain a more thorough understanding 

of how to utilize telehealth technologies 

through telehealth to improve access to, 

and improve the quality of, health care 

services. 

A 60-day notice published in the 

Federal Register on August 18, 2023, 88 

FR 56640–41. There were no public 

comments, but OAT made minor 

adjustments to the numbering, wording, 

and some categories on the Rural 

Telehealth Research Center Data 

Dictionary and accompanying Direct-toConsumer Telehealth Evidence 

Collection tool to increase ease of use. 

Need and Proposed Use of the 

Information: The measures will enable 

HRSA and OAT to capture data that 

illustrate the impact and scope of 

federal funding along with assessing 

these efforts. The measures cover the 

principal topic areas of interest to OAT, 

including: (1) population demographics, 

(2) access to health care, (3) cost savings 

and cost-effectiveness, and (4) clinical 

outcomes. 

Likely Respondents: The likely 

respondents are award recipients of the 

Evidence Based Telehealth Network 

Program. 

Burden Statement: Burden in this 

context means the time expended by 

persons to generate, maintain, retain, 

disclose, or provide the information 

requested. This includes: the time 

needed to review instructions; to 

develop, acquire, install, and utilize 

technology and systems for the purpose 

of collecting, validating, and verifying 

information, processing and 

maintaining information, and disclosing 

and providing information; to train 

personnel and to be able to respond to 

a collection of information; to search 

data sources; to complete and review 

the collection of information; and to 

transmit or otherwise disclose the 

information. The total annual burden 

hours estimated for this ICR are 

summarized in the table below. 

Total estimated annualized burden hours: instrument 

name 

Number of 

respondents 

Number of 

responses per 

respondent 

Total 

responses 

Average 

burden per 

response 

(in hours) 

Total burden 

hours 

Evidence-Based Telehealth Network Program Report ........ 11 4 44 31 1,364 

Telehealth Performance Measurement Report ................... 11 1 11 5 55 

Total .............................................................................. * 11 ........................ 55 ........................ 1,419 

* HRSA estimates 11 unique respondents, each completing the two forms. 

HRSA specifically requests comments 

on: (1) the necessity and utility of the 

proposed information collection for the 

proper performance of the agency’s 

functions; (2) the accuracy of the 

estimated burden; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) the 

use of automated collection techniques 

or other forms of information 

technology to minimize the information 

collection burden. 

Maria G. Button, 

Director, Executive Secretariat. 

[FR Doc. 2023–26248 Filed 11–28–23; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Submission to OMB for 

Review and Approval; Public Comment 

Request; Rural Health Network 

Development Program Performance 

Improvement Measurement System, 

OMB No. 0906–0010–Revision 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Notice. 

SUMMARY: In compliance with the 

Paperwork Reduction Act of 1995, 

HRSA submitted an Information 

Collection Request (ICR) to the Office of 

Management and Budget (OMB) for 

review and approval. Comments 

submitted during the first public review 

of this ICR will be provided to OMB. 

OMB will accept further comments from 

the public during the review and 

approval period. OMB may act on 

HRSA’s ICR only after the 30-day 

comment period for this notice has 

closed. 

DATES: Comments on this ICR should be 

received no later than December 29, 

2023. 

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 information 

collection by selecting ‘‘Currently under 

Review—Open for Public Comments’’ or 

by using the search function. 

FOR FURTHER INFORMATION CONTACT: To 

request a copy of the clearance requests 

submitted to OMB for review, email 

Joella Roland, the HRSA Information 

Collection Clearance Officer, at 

paperwork@hrsa.gov or call (301) 443– 

3983. 

SUPPLEMENTARY INFORMATION: 

Information Collection Request Title: 

Rural Health Network Development 

Program Performance Improvement 

Measurement System, OMB No. 0906– 

0010–Revision. 

Abstract: The Rural Health Network 

Development (RHND) program is 

authorized under section 330A(f) of the 

Public Health Service Act (42 U.S.C. 

254c(f)). The purpose of this program is 

to support integrated health care 

networks that collaborate to achieve 

efficiencies; expand access to, 

coordinate, and improve the quality of 

basic health care services and associated 

health outcomes; and strengthen the 

rural health care system as a whole. The 

program supports networks as they 

address gaps in service, enhance 

systems of care, and expand capacity of 

the local health care system. 

RHND-funded programs promote 

population health management and the 

transition towards value-based care 

through diverse network participants 

that include traditional and 

nontraditional network partners. 

Evidence of program impact 

demonstrated by outcome data and 

program sustainability are integral 

components of the program. This is a 4- 

year competitive program for networks 

composed of at least three participants 

that are existing health care providers. 

At least 66 percent of network 


ddrumheller on DSK120RN23PROD with NOTICES1